5 — Class II medical device recall Z-1935-2013
Terminated recall by Synthes USA HQ, Inc., reported 2013-08-21, distributed nationwide. DePuy Synthes has issued a Medical Device Correction notice for the 5.0mm Stainless Steel rods. This product w
| Recall number | Z-1935-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Synthes USA HQ, Inc., West Chester, PA, United States |
| Recall initiated | 2013-06-05 |
| Classified | 2013-08-09 |
| Reported by FDA | 2013-08-21 |
| Terminated | 2015-09-21 |
| Distributed | Nationwide (US) |
| Quantity | 492 |
| Lot numbers | 1602596, 1602617, 1880489, 2002330, 3000595, 3016224, 3080451, 3093619, 4729951, 4729952, 4729953, 4729954, 4729956, 4729958, 4729959, 4729960, 4729961, 4729962, 4835367, 4835368, 4835378, 4841209, 4841210, 4841211, 4841212, 4841213, 4856246, 4856248, 4856249, 4856250, 4856252, 4856275, 4919162, 4919165, 4923615, 4923651, 4923652, 4923653, 4923654, 4923655 and 43 more |
| Model numbers | 298.269, 298.270, 298.271, 298.272, 298.273, 298.274, 298.275, 298.276, 298.277, 298.278 |
Product
5.0mm Unit Rod 270mm 5.0mm Unit Rod 290mm 5.0mm Unit Rod 310mm 5.0mm Unit Rod 330mm 5.0mm Unit Rod 350mm 5.0mm Unit Rod 370mm 5.0mm Unit Rod 390mm 5.0mm Unit Rod 410mm 5.0mm Unit Rod 430mm 5.0mm Unit Rod 450mm pedicle screw spinal system; Intended to provide immobilization and stabilization of spinal segments in skeletally mature patients.
Reason for recall
DePuy Synthes has issued a Medical Device Correction notice for the 5.0mm Stainless Steel rods. This product was produced using a finishing process not identified as part of the manufacturing specification. No adverse event reports associated with the use of this product were received, and an extensive engineering and medical safety review concluded that the product poses no incremental risk to t
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-1935-2013. 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.