- Recalling firm
- F & A Foundation
- Reason for recall
- Bone fixation staple requires a new 510(k); the performance characteristics of this device have not been adequately established.
- Affected products (lot / model / serial)
- REF/UDI-DI/Lot/Expiration: 152-30907/00854325007011/24-0627/10/27/2029, 152-31110/00854325007028/24-0628/10/21/2029, 152-31512/00854325007042/24-0629/10/22/2029, 152-31818/00854325007073/24-0630/10/23/2029, 152-32020/00854325007189/24-0631/10/28/2029, 152-40907/00854325007010/24-0633/10/16/2029, 152-41110/00854325007127/24-0634/10/20/2029, 152-41512/00854325007141/24-0635/10/20/2029, 152-41818/00854325007172/24-0636/10/16/2029, 152-42020/00854325007189/24-0637/10/16/2029
- Units affected
- 600
- Distribution pattern
- US Nationwide distribution in the states of TX, OK, MD, VT, MA, LA.
- Firm location
- Tulsa, OK, United States
- Recall type
- Voluntary: Firm initiated
- How the firm notified customers
- N/A
- Product type
- Devices
- Status
- Ongoing
- Recall number
- Z-3211-2026
- Recall initiated
- July 15, 2026
- FDA classification date
- September 17, 2026
- FDA report date
- September 23, 2026
- FDA event ID
- 99515
- Last updated on HTM Vibe
- September 29, 2026