RegWardenFDA facility compliance records
Company

WALDEMAR LINK GMBH & CO. KG

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

Recalls by year

FDA actions on record by year2013: 1 recalls; 2018: 2 recalls; 2021: 1 recalls; 2022: 2 recalls; 2023: 4 recalls; 2024: 6 recalls; 2025: 5 recalls; 2026: 3 recalls1’13’14’15’16’172’18’19’201’212’224’236’245’253’26
  • Recalls (24)

Registered facilities (1)

Recalls & enforcement

20263 records
  • Class IIOngoing2026-07-06
    The affected Endo-Model replacement set for a Rotating Hinge tibial plateau incorrectly contains a Pure Hinge plateau. The incorrect plateau could lead to a prolonged or modified surgery as the plateau cannot be inserted and an alternative product would be needed. If the incorrec…
  • Class IIOngoing2026-02-11
    The surgical technique for the Embrace Shoulder Instruments - Drill Tower has mixed-up article numbers in the overview of the instruments. However, the individual surgical steps described in the surgical technique are correct.
  • Class IIOngoing2026-01-12
    The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture.
20255 records
  • Class IIOngoing2025-11-10
    The device has been delivered with a preassembled locking screw that had been inserted from the wrong side into the male taper of the femoral component.
  • Class IIOngoing2025-07-31
    Some modular LinkSymphoKnee TiNbN Tibial Components were manufactured with two uncoated security screws, which is incorrect.
  • Class IIOngoing2025-07-15
    Inconsistent size terminology and color coding used on labeling
  • Class IIOngoing2025-04-03
    The device was delivered with a preassembled Femoral Augment screw that was missing its thread.
  • Class IIOngoing2025-02-14
    A problem was discovered during the scanning process of the outer carton label because of an incorrect GTIN on the label, which is a GTIN for a different product.
20246 records
  • Class IIOngoing2024-12-05
    Error on the main label and the patient label. The labels indicate a size XXL, this is a standard-size neck segment.. All further information on the labels is correct (Length, CCD and Offset).
  • Class IIOngoing2024-09-11
    Some lots of the LINK Universal Handle, with quick coupling, Stainless Steel, straight may suffer an immediate material failure intraoperatively when the instrument is used for the first time. The instrument can break in the middle.
  • Class IIOngoing2024-05-22
    Blind screws of the modular tibial component cannot be loosened intraoperatively,prolongation surgery due to intraoperatively change in procedure, probably to cementing technique
  • Class IIOngoing2024-02-06
    Due to two complaints, has come to our attention that additional guidance is required on the correct interpretation of the carton label Size and Type columns to avoid misinterpretation during surgery.
  • Class IIOngoing2024-01-29
    The surgical techniques for the Embrace Shoulder Instruments -Drill Tower (Article REF 645-081/62 & /63) have mixed-up type descriptions ("standard" vs "wedged") in the overview of the instruments.
  • Class IIOngoing2024-01-22
    Mislabeled: Packaging incorrectly reflects a MobileLink Dual Mobility insert type F when it should reference G may cause a delay in surgery
20234 records
  • Class IIOngoing2023-11-30
    Mislabeled: Angle and height of the device marked as L(large) corresponds to the small/medium dimensions due to a product mix-up. This may result in too little bone material resected and not fit correctly leading to extended surgery time
  • Class IIOngoing2023-07-26
    A crack in the weld of the rasp handle may lead to a fracture of the frontal sleeve when the rasp is further impacted or extracted. The rasp remains intact. The rasp would need to be pulled out by a clamp leading to a prolongation of surgery or modified surgery
  • Class IIOngoing2023-07-14
    Product is labeled with incorrect offset.
  • Class IIOngoing2023-07-03
    Increased force may be required to remove the LINK MP Monoblock trial hip stem (Sizes 14mm - 25mm),after impaction. Potential for prolongation of surgery or the surgical procedure may have to be modified due to this issue
20222 records
  • Class IIOngoing2022-12-23
    Fixation screw was inserted through the wrong side of the augment (distal to proximal, as opposed to proximal to distal, which is the correct orientation).
  • Class IIOngoing2022-05-24
    There is a risk that blind screws of the modular tibial component cannot be loosened intraoperatively. This may lead to prolongation of surgery due to an intraoperative change in procedure.
20211 record
20182 records
  • Class IITerminated2018-12-07
    The reaming guide and the guide rod can't be screwed into the intended depth. The reason for this is a reduced depth of the core hole in the stem. A reaming guide that is not screwed in completely may lead to a proximal preparation in the depth that is not sufficient and to a nec…
  • Class IITerminated2018-12-04
    The internal labeling included with these implants may include incorrect part numbers and could result in these incorrect labels being added to patient records.
20131 record

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. We restate the public record only — measured facts, never risk verdicts.

Cite this record

RegWarden. “WALDEMAR LINK GMBH & CO. KG — FDA compliance profile.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/company/oo-8010091-waldemar-link-gmbh-co-kg/

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