FDA Medical Device Recalls (openFDA)
Wright Medical Technology, Inc.: ORTHOLOC 3DSi CLAW II 4 HOLE Plate, Size 25MM, REF 40241425, Bone fixation device
- Recall number
- Z-1170-2023
- Recalling firm
- Wright Medical Technology, Inc.
- Product
- ORTHOLOC 3DSi CLAW II 4 HOLE Plate, Size 25MM, REF 40241425, Bone fixation device
- Status
- Open, Classified
- Initiated
- 2023-02-02
- Posted
- 2023-02-24
- Terminated
- not on file
- Reason
- Stryker has identified an issue that impacts two specific lots of CLAW" II plates. The plates within these two lots were found to have been comingled, resulting in the incorrect product in packages. Packaging for 402S0425 incorrectly contained 40241425, and vice versa.
- Root cause
- Employee error
- Action
- The firm issued an URGENT MEDICAL DEVICE notice to its the sole consignee by email on 02/02/2023. The notice explained the product and the issue and requested the following actions be taken: 1. Check inventory for affected product and remove from use 2, Sign and return the enclosed Business Reply Form by email to fieldaction@stryker.com to confirm receipt of this notification/documenting product disposition. Stryker will will contact you to arrange for the return of the affected device(s) 3. Maintain awareness of this communication internally until all required actions have been completed within your facility.. 4. If you have further distributed the affected product, please notify the applicable parties at once about this recall. You may copy and distribute this notification letter. a. If possible, inform us if any of the subject devices have been distributed to other organizations, including contact details so that we can inform the recipients appropriately. b. If you are a distributor, note that you are responsible for notifying your affected customers.
- Quantity
- 4 units
- Distribution
- US Nationwide distribution in the state of NY.
- Lot, serial or model codes
- GTIN 00840420110770, Lot Number 1636042
- 510(k) numbers
- ["K113014"]
- 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