Facility

Arthrex GmbH

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)	3002579136
Establishment type	Export Device to the United States But Perform No Other Operation on Device
Location	Erwin-Hielscher-Strasse 9 Munich Bavaria, DE 81249
Registration status	Active · expires 2026
Parent company	ARTHREX, INC. (owner-operator 1220287)
Brand names	BIO-CORKSCREW FT

Activity by year

Recalls (18)

Devices registered here (1)

Screw, Fixation, Bone
Product code HWC (opens in a new tab) · Class II · Orthopedic · 21 CFR 888.3040

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 GmbH (FEI 3002579136) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3002579136-arthrex-gmbh/

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