FDA Medical Device Recalls (openFDA)
Wright Medical Technology, Inc.: Wright Medical Technology, Inc. ORTHOLOC Non-Locking Screw 2mm x 8mm, REF 5201120008, non-sterile, a component of the ORTHOLOC 2.0/2.4 Plate System.
- Recall number
- Z-0786-2022
- Recalling firm
- Wright Medical Technology, Inc.
- Product
- Wright Medical Technology, Inc. ORTHOLOC Non-Locking Screw 2mm x 8mm, REF 5201120008, non-sterile, a component of the ORTHOLOC 2.0/2.4 Plate System.
- Status
- Terminated
- Initiated
- 2022-02-15
- Posted
- not on file
- Terminated
- 2022-10-05
- Reason
- An incorrect screw is packaged in the product, which contains a locking screw instead of a non-locking screw.
- Root cause
- Process control
- Action
- The firm notified the foreign competent authority via email on 2/15/2021 which included a copy of the recall letter. Once the foreign competent authority approves the recall, the recall letter will be sent to the foreign consignee. The recall letter is dated 2/15/2022 and describes the product, the issue, potential risks, and the actions needed. The actions included (1) informing individuals within their organization who need to be aware of this device recall; (2) immediately check all stock areas and/or operating room storage to determine if there is any affected product; (3) quarantine and discontinue use of the recalled device; (4) complete the business reply form and a Stryker representative will contact the customer to arrange for return and replacement of the device; (5) inform Stryker if the device has been distributed to other organizations. If so, provide contact details so that Stryker can inform the recipient appropriately. If the consignee is a distributor, they are responsible for notifying the affected customers; and (6) inform Stryker of any adverse events concerning the use of the device.
- Quantity
- 1 package
- Distribution
- International distribution to the country of France.
- Lot, serial or model codes
- Lot #73967511638696
- 510(k) numbers
- ["K090692"]
- PMA numbers
- not on file
- Product code
- HRS
- Firm FEI
- 3010667733
- Firm city
- Memphis
- Firm state
- TN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28