Facility

Arthrex Mexico, S.A. de C.V.

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

Key facts

18recalls · worst Class II

—inspections in our data

—warning letters in our data

Recalls are listed for the parent company: openFDA recall records do not name a facility. How we attribute records

FDA Establishment Identifier (FEI)	3011230048
Establishment type	Export Device to the United States But Perform No Other Operation on Device
Location	Insurgentes Sur No. 859, Oficina 101 Col. Napoles Mexico, MX 03810
Registration status	Active · expires 2026
Parent company	ARTHREX, INC. (owner-operator 1220287)
Brand names	Instrument, manual, surgical, general use

Activity by year

Recalls (18)

Devices registered here (1)

Instrument, Manual, Surgical, General Use
Product code MDM (opens in a new tab) · Class I · General, Plastic Surgery · 21 CFR 878.4800

Recalls & enforcement

20222 records

Class IIOngoing2022-11-02
The devices may be packaged with the wrong reamer size.
Class IITerminated2022-03-25
Products do not meet length and diameter specifications.

20213 records

Class IIOngoing2021-06-14
Not properly sterilized, because the outer pouch seal on the Tyvek header was sealed closely to the foil pouch.
Class IITerminated2021-03-11
It was discovered that five AR-13200ST-15.0 parts were processed as AR-13200T-15.0 parts.
Class IITerminated2021-02-24
The color indicator on the proximal end of the shaft of the AR-8770-02 is the incorrect color.

20201 record

Class IITerminated2020-06-24
Screws provided in packaging are 5mm shorter than intended

20193 records

Class IITerminated2019-12-17
There is a potential for blockage of the Hub Attachment Tube.
Class IITerminated2019-10-01
Screws provided in the device package are 6 mm longer than intended.
Class IITerminated2019-01-14
Devices may generate excessive heat during use.

20183 records

Class IIOngoing2018-11-19
Potentially lead to anchor breakage during insertion,
Class IIOngoing2018-09-13
There is potential to break during use.
Class IIOngoing2018-08-27
The Li-ion Battery Housing for the AR-400 DrillSaw Sports 400 System may not provide a complete seal around the battery, allowing for potential fluid ingress.

20172 records

Class IITerminated2017-10-03
Arthrex part number AR-501-UFLC, size 3, batch 10123297, has the incorrect part number AR-501 UFRA, size 1 printed on the patient label inside the box.
Class IITerminated2017-03-24
Some eyelets broke from SwiveLock Anchor on insertion.

20163 records

Class IIITerminated2016-08-12
The device was assembled incorrectly. Suture and washer were not assembled; components were placed loose in the package.
Class IITerminated2016-04-22
Potential for polystyrene particulate presence.
Class IITerminated2016-01-11
Potential for a component contained in the Implant System to be non-sterile.

20151 record

Class IITerminated2015-12-17
Devices reported to have a smooth texture to the outer surface of the metal, which differed from a previous that had a textured outer surface.

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. “Arthrex Mexico, S.A. de C.V. (FEI 3011230048) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3011230048-arthrex-mexico-s-a-de-c-v/

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