Thumb Screw for the Synthes Recon Locking Aiming Arm for Lateral… — Class II medical device recall Z-1281-2015
Terminated recall by Synthes, Inc., reported 2015-03-25, distributed nationwide. For certain lots, the incorrect raw material of annealed 17-4PH Stainless Steel was used instead of the correc
| Recall number | Z-1281-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Synthes, Inc., West Chester, PA, United States |
| Recall initiated | 2015-02-17 |
| Classified | 2015-03-16 |
| Reported by FDA | 2015-03-25 |
| Terminated | 2016-08-26 |
| Distributed | Nationwide (US) |
| Quantity | 183 |
| Reason classes | packaging |
| Lot numbers | 4784017, 4874015, 4874016, 4874018, 4874019, 4874020, 4874021, 4874022, 4899564, 4899565, 4922533, 4922970, 4922971, 4922972, 4922973, 4922974, 4922975, 4923015, 4927260, 4927261, 4927262, 4944750, 4944751, 4954478, 4954479, 4954480, 4954481, 4957586, 4957587, 4957588, 4957589, 4963190, 4963192, 4963193, 4972003, 4972004, 4977241, 4977242, 4981156, 4981157 and 6 more |
| Model numbers | 03.010.048, 03.010.052 |
Product
Thumb Screw for the Synthes Recon Locking Aiming Arm for Lateral Entry Femoral Nails-EX (part number 03.010.048) and the Thumb Screw for the Aiming Arm for Titanium Cannulated Tibial Nails-EX (part number 03.010.052). The Recon Locking Aiming Arm for Lateral Entry Femoral Recon Nails- EX is used when locking the Femoral Nail-EX. The Aiming Arm for Titanium (TI) Cannulated Tibial Nails-EX is used when locking the Tibial Nail-EX.
Reason for recall
For certain lots, the incorrect raw material of annealed 17-4PH Stainless Steel was used instead of the correct material of heat-treated 304 Stainless Steel. This may lead to stress-corrosion cracking, which can lead to surgical delay or unintended debris entering the surgical site.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1281-2015. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.