RegWardenFDA facility compliance records
Facility

Mathys AG Bettlach

61 recall(s) on record — most severe on record: Class II.

Activity by year

FDA actions on record by year2012: 3 recalls; 2013: 1 recalls; 2015: 5 recalls; 2016: 5 recalls; 2017: 8 recalls; 2018: 7 recalls; 2019: 2 recalls; 2020: 5 recalls; 2021: 3 recalls; 2022: 3 recalls; 2023: 9 recalls; 2024: 2 recalls; 2025: 5 recalls; 2026: 3 recalls3’121’13’145’155’168’177’182’195’203’213’229’232’245’253’26
  • Recalls (61)

Devices registered here (1)

  • Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
    Product code LZO (opens in a new tab) · Class II · Orthopedic · 21 CFR 888.3353

Recalls & enforcement

20263 records
  • Class IIOngoing2026-02-16
    Due to packaging discrepancy with incorrect product size mixed up.
  • Class IIOngoing2026-01-15
    Knee and Humeral socket implants contain incorrect labeling.
  • Class IIOngoing2026-01-05
    942-01-40G acetabular system package was found to contain 942-01-36H acetabular system; and several other acetabular system and knee insert devices may also have a packaging discrepancy, which may cause surgical delay to exchange devices or revision surgery.
20255 records
  • Class IIOngoing2025-07-18
    Their is a potential that the reamer may kick or bind up during or immediately prior to use.
  • Class IIOngoing2025-07-09
    Knee implants contain incorrect labeling (size and/or side incorrect)
  • Class IIOngoing2025-06-12
    Due to packaging discrepancy with the incorrect tibial inserts/implants being packaged. Issued discovered via a customer complaint.
  • Class IIOngoing2025-06-02
    Due to packaging discrepancy with the incorrect tibial inserts/implants being packaged. The use of this product may result in the incorrect product being selected. This could result in a revision surgery if used.
  • Class IIOngoing2025-05-28
    Package labeling for Altivate Reverse Torx Peripheral screw contains a different size then actual included product.
20242 records
  • Class IIOngoing2024-12-18
    5R 16MM knee tibial insert package may contain knee tibial insert 3R 14MM and vice versa, which may cause surgical delay to get a new product.
  • Class IIOngoing2024-12-10
    Knee insert package may contain an acetabular system, which may cause surgical delay to get a new product.
20239 records
  • Class IIOngoing2023-11-10
    Due to incorrect product/device within packaging.
  • Class IICompleted2023-10-05
    Mislabeling
  • Class IIOngoing2023-09-29
    Knee punch handle tip is breaking during surgery due to the lack of heat treatment, which may lead to a disruption in surgery.
  • Class IIOngoing2023-09-25
    Two different humeral socket Insert devices were swapped during packaging, which could result in surgeons not having the correct device for surgery, which could cause a delay in surgery.
  • Class IIOngoing2023-09-06
    Coating hex did not engage with the Straight Mod Hexdriver or with the Hex Head Screw Driver
  • Class IIOngoing2023-08-22
    Knee insert and acetabular system parts were swapped within inner pack prior to the product being sealed within the tray, which could result in surgeons not having the correct product for the surgery due to different anatomies (Hip vs Knee).
  • Class IIOngoing2023-08-22
    Reverse shoulder prosthesis package that should contain 5mmx30 screws could contain incorrect 3.5mmx30 screws. Use of incorrect screws could result in surgical delay and inadequate fixation.
  • Class IIOngoing2023-08-04
    Orthopedic device components were not subjected to final sterilization before shipment, which if implanted may lead to varying degrees of infection, which may require treatment, prolonged monitoring, and may lead to revision surgery
  • Class IIOngoing2023-02-28
    Patella drills are marked with incorrect diameter size of 5.6mm, when they should be 5.4mm. Porous patella overdrills are marked with incorrect diameter size of 5.4 mm, when they should be 5.6 mm. If the incorrect drill is selected during surgery, there is risk of the implant loo…
20223 records
  • Class IIOngoing2022-12-22
    Tibial insert implant large boxes were labeled small and the small boxes were labeled large. If the incorrect labeling is identified this could lead to surgical delay and if the surgeon does not recognize the size discrepancy between the insert label and the pin label, the surgeo…
  • Class IIOngoing2022-08-12
    Hip liner implant boxes may contain knee inserts and knee insert boxes may contain hip liner implants, which may lead to implants not being available for surgeries, which may cause delays in surgery.
  • Class IIOngoing2022-05-05
    A right, size 8, knee tibial insert package may include a mispackaged, left ,size 4, knee tibial insert. If implanted, a risk may include leaving debris in the joint space.
20213 records
  • Class IIOngoing2021-06-28
    Complaints have been received concerning the humeral stem failing to mate with the broach handles for a shoulder device. This could result in delay of procedure or revision surgery.
  • Class IIOngoing2021-05-12
    Packaging mixup; There is a potential that packaging identified as 12mm knee prosthesis contains 16mm knee prosthesis and 16mm knee prosthesis packaging contains 12 mm knee prosthesis.
  • Class IIOngoing2021-02-05
    Incorrect assembly of a subcomponent by a vendor and as a result, the windows provided to show the size are facing the opposite direction.
20205 records
  • Class IIOngoing2020-09-09
    Due to incomplete machining a small peg remnant on the top of the dome that protrudes above the surrounding porous coating causing the cup not to seat properly.
  • Class IITerminated2020-08-31
    Product mislabeled. Use may result in a delay in surgery, stopping of surgery, and revision surgery.
  • Class IIOngoing2020-08-07
    Product may be mislabeled with the size etched onto products differing from the size information shown on patient sticker labels. Risks associated with this issue may include the Surgeon implanting the incorrect size; significant physical impairment, discomfort and/or disruption …
  • Class IIOngoing2020-08-03
    There is a potential for the retaining pin of the tibial punch handle to become loose and fall out while impacting. If undetected, there is a potential of leaving debris in the joint space.
  • Class IIOngoing2020-06-19
    There have been issues experienced with the peg preparation steps, specifically drilling of the Femoral posterior peg. Upon drilling, the shaft portion of the drill may bind within the Posterior Peg drill guide. The extended length of the drill guide and tight tolerances to ensur…
20192 records
  • Class IIOngoing2019-10-22
    The firm received complaints that the EMPOWR Acetabular Impactor Balls were fracturing/cracking during impaction which could cause debris to migrate or be left in the joint space.
  • Class IIOngoing2019-02-04
    The firm has received reports/complaints concerning the breakage of the tips of the locking femoral Impactor. Additionally, if the impactor is not seated correctly on the implant prior to impaction, this may cause off axis loading which can increase the risk of device failure. T…
20187 records
  • Class IITerminated2018-09-21
    Complaints regarding loose proximal body bolts or bolts that were found through x-ray as sitting above the proximal body and not properly seated. Patient risks may include: pain, dissociation, and possible revision surgery
  • Class IIOngoing2018-09-19
    Manufacturing error, the drill bit shaft is unable to properly capture the drill bit pin. Failure of the drill bit shaft to capture the drill bit pin could result in the drill bit coming loose which could result in a delay in surgery or adverse patient reaction resulting in a …
  • Class IIOngoing2018-07-10
    The retaining ring on the neck trials has a potential to fail interoperatively.
  • Class IITerminated2018-06-26
    A black, aluminum oxide coating may appear on the tray after cleaning. The black, aluminum oxide coating is not biocompatible.
  • Class IITerminated2018-05-14
    After receipt of a product complaint for the labeling, it was determined that this device does not have FDA clearance.
  • Class IITerminated2018-01-30
    Broken or missing screws and retaining clips. This may be due to screw tolerance and material strength of the trial.
  • Class IICompleted2018-01-29
    It was discovered during a surgery that the design of the radius at the base of the pegs of the Anatomic Glenoid Trial (Part Numbers: 804-07-380, 804-07-420, 804-07-460, 804-07-500, and 804-07-540) is much larger on the trails than on the implants
20178 records
  • Class IITerminated2017-12-12
    The Locking Punch Guide was not sufficiently guiding the large press fit punch, causing the implant to be placed 2-3mm more posterior than intended.
  • Class IITerminated2017-09-15
    It was reported that an implant labeled as 343-13-708 was packaged with implant 343-19-707.
  • Class IITerminated2017-08-04
    It was reported that the models used to manufacture S-200956/958 had the wrong dimension used to create the spherical radius cutting surface. Device design allows a larger spherical radius cutting surface than intended.
  • Class IIOngoing2017-06-26
    Loss of the seal on the sterile Tyvek packaging used with this Cobalt Bone Cement.
  • Class IITerminated2017-05-31
    Mis-pack. A size 6 Left 3DKnee Tibial Insert box and pouch contained a Size 8 right 3Dknee Tibial Insert.
  • Class IITerminated2017-02-09
    During the Turon assembly, the impaction forces caused the polymer, black acetal copolymer from the Impaction Fixture to wear off on the lateral surface of the Humeral Stem titanium plasma spray coating.
  • Class IITerminated2017-01-10
    The Empowr PS Insert was reported as missing the impaction slot feature.
  • Class IITerminated2017-01-10
    Lima Proximal Bodies were inadvertently re-sterilized. The safety screw which affixes the distal and proximal bodies of the stem includes a thread-locking plug made from UHMWPE, which is not approved for repeated gamma sterilization.
20165 records
  • Class IITerminated2016-11-15
    A size 4 Empowr baseplate was mislabeled as a size 6. The affected lot was laser marked as M6, marked with the lot number for the size 6 minus lot, and distributed as size 6 minus.
  • Class IITerminated2016-09-19
    It has been discovered that during Empowr PS Total Knee replacement, while chiseling for bone removal in the box area, femoral chipping has occurred in surgery. The current design of the captured box cut guides can create an instance where the surgeon is not fully completing the …
  • Class IITerminated2016-09-19
    It has been discovered that during Empowr PS Total Knee replacement, while chiseling for bone removal in the box area, femoral chipping has occurred in surgery.
  • Class IITerminated2016-07-26
    The outer packaging was mislabeled on the box indicating "Cobalt HV with Gentamicin". The bone cement does not contain antibiotics.
  • Class IITerminated2016-06-21
    Reported failure of the instrument. The retaining ring component of a neck trial became disassembled from the body of the neck.
20155 records
  • Class IITerminated2015-12-08
    The trial shell mating feature on the broach is undersized.
  • Class IITerminated2015-09-16
    The labeling is missing the size/diameter information.
  • Class IITerminated2015-09-15
    Difficulty assembling the shell trial to the broach and the retaining ring disassembled from the screw.
  • Class IITerminated2015-09-14
    During the Turon assembly, the impaction forces caused the polymer, black acetal copolymer form the Impaction Fixture to wear off on the lateral surface of the Humeral Stem titanium plasma spray coating.
  • Class IITerminated2015-06-24
    The markings on the distal face of the instruments are mis-oriented by 180®. This includes Anterior and Posterior, which the surgeon uses to correctly place the cut block on the resectioned face of the femur. The cut block is not symmetric, so correct orientation of the instrumen…
20131 record
  • Class IITerminated2013-04-01
    U.S. Agent contacted Director Commercial Logistics, notifying him of incorrect color coded labels on two packages of e+tibial inserts. There were 8 e+ tibial inserts of the same lot number in Finished Goods as the two from the agency. These devices were inspected and all were in…
20123 records
  • Class IITerminated2012-09-28
    A product complaint was received where a size 20 screw was labeled as size 30. After receipt, measurement of the screw determined it to be a size 25. Further investigation also determined that there were other screws labeled as size 25, but a size 30 screw was inside of the pack…
  • Class IITerminated2012-08-09
    The firm is recalling one lot of 392-09-706, 3DKnee e+ Tibial insert, 9 mm, Size 6, Right. The shelf life labeling of specific lots for a component were found to be incorrect and were found to be expired.
  • Class IITerminated2012-07-16
    One lot of the 010-55-030, 6.5 mm Cancellous Bone Screw was recalled because a product complaint identified a mislabeling of the device. Although the package label indicates Size 30mm, the screw dimension is actually 25mm.

Related

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this facility record at FDA → (opens in a new tab)

Cite this record

RegWarden. “Mathys AG Bettlach (FEI 3012439458) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3012439458-mathys-ag-bettlach/

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