ARTHREX, INC.
18 recall(s) on record — most severe on record: Class II.
Recalls by year
- Recalls (18)
Registered facilities (20)
- Arthrex Singapore Pte Ltd. FEI 3014004349 · SG
- Arthrex New Zealand Limited FEI 3020704423 · NZ
- Arthrex Mexico, S.A. de C.V. FEI 3011230048 · MX
- Arthrex Australia Pty Ltd. FEI 3019269298 · AU
- Arthrex do Brazil Importacao e Comercio de Equipamentos Medicos Ltda FEI 3015974593 · BR
- Arthrex Colombia SAS FEI 3021226419 · CO
- Arthrex Distribution Hub EMEA B.V. FEI 3016851379 · NL
- Arthrex Korea Ltd. FEI 3013700547 · KR
- Arthrex Manufacturing Inc. FEI 3015231789 · SC
- Arthrex Chile SPA FEI 3027339877 · CL
- Arthrex Logistic Center Canada FEI 3030926959 · CA
- Arthrex GmbH FEI 3002579136 · DE
- Arthrex, Inc. FEI 3010331645 · FL
- Arthrex California Technology, Incorporated FEI 3006990600 · CA
- ARTHREX, INC. FEI 1220246 · FL
- Arthrex (Shanghai) Co., Ltd. FEI 3014262693 · CN
- Arthrex Logistic Center FEI 3009423112 · FL
- ARTHREX GMBH FEI 3007193505 · DE
- Arthrex Japan G.K. (Shinjuku) FEI 3012470322 · JP
- Arthrex Medical Device (Shanghai) Co. Ltd. FEI 3031238646 · CN
Recalls & enforcement
20222 records
- Class IIOngoing2022-11-02The devices may be packaged with the wrong reamer size.
- Class IITerminated2022-03-25Products do not meet length and diameter specifications.
20213 records
- Class IIOngoing2021-06-14Not properly sterilized, because the outer pouch seal on the Tyvek header was sealed closely to the foil pouch.
- Class IITerminated2021-03-11It was discovered that five AR-13200ST-15.0 parts were processed as AR-13200T-15.0 parts.
- Class IITerminated2021-02-24The color indicator on the proximal end of the shaft of the AR-8770-02 is the incorrect color.
20201 record
- Class IITerminated2020-06-24Screws provided in packaging are 5mm shorter than intended
20193 records
- Class IITerminated2019-12-17There is a potential for blockage of the Hub Attachment Tube.
- Class IITerminated2019-10-01Screws provided in the device package are 6 mm longer than intended.
- Class IITerminated2019-01-14Devices may generate excessive heat during use.
20183 records
- Class IIOngoing2018-11-19Potentially lead to anchor breakage during insertion,
- Class IIOngoing2018-09-13There is potential to break during use.
- Class IIOngoing2018-08-27The 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 IITerminated2017-10-03Arthrex 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 IITerminated2017-03-24Some eyelets broke from SwiveLock Anchor on insertion.
20163 records
- Class IIITerminated2016-08-12The device was assembled incorrectly. Suture and washer were not assembled; components were placed loose in the package.
- Class IITerminated2016-04-22Potential for polystyrene particulate presence.
- Class IITerminated2016-01-11Potential for a component contained in the Implant System to be non-sterile.
20151 record
- Class IITerminated2015-12-17Devices 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. We restate the public record only — measured facts, never risk verdicts.
Cite this record
RegWarden. “ARTHREX, INC. — 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-1220287-arthrex-inc/
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