FDA Medical Device Recalls (openFDA)
Wright Medical Technology Inc: Stryker DARCO Screw, Locking, Ti6A14V, REF DC2825016, 2.7mm x 16mm.
- Recall number
- Z-0393-2022
- Recalling firm
- Wright Medical Technology Inc
- Product
- Stryker DARCO Screw, Locking, Ti6A14V, REF DC2825016, 2.7mm x 16mm.
- Status
- Open, Classified
- Initiated
- 2021-12-03
- Posted
- not on file
- Terminated
- not on file
- Reason
- The incorrect product is contained in the packaging.
- Root cause
- Under Investigation by firm
- Action
- The recalling firm issued a recall letter dated 03 Dec 2021 on 12/3/2021 via Fed Ex Priority Overnight. The letter explained the packages labeled as the CLAW II 4 Hole Plates and the packages labeled as the DARCO Locking Screws were switched, resulting in the packages containing the incorrect product. The letter also provided the potential risks, the actions needed to be taken, and provided example labels of affected products. The consignee is to immediately check their inventory to locate the packaged product and remove them from their point of use. The enclosed business reply form was to be returned via email to confirm receipt of the letter and document product segregation. After the firm receives the reply form, the consignee will be contacted to arrange for return and replacement. The consignee was given the choice of providing subdistribution contact details to the recalling firm so the recalling firm could inform them of the recall, or the consignee can notify their downstream customers of the recall.
- Quantity
- 250 units
- Distribution
- Worldwide distribution in the states of AZ, IA, ID, NC, NY, VA, and WV. The countries of Canada, France, Germany, Lebanon, The Netherlands, Saudi Arabia, and United Kingdom.
- Lot, serial or model codes
- Lot #1643355
- 510(k) numbers
- ["K061808"]
- PMA numbers
- not on file
- Product code
- HRS
- Firm FEI
- 1043534
- Firm city
- Arlington
- 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