5 — Class II medical device recall Z-0134-2016
Terminated recall by Synthes (USA) Products LLC, reported 2015-10-28, distributed nationwide. This product was produced using a finishing process not identified as part of the manufacturing specification.
| Recall number | Z-0134-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Synthes (USA) Products LLC, West Chester, PA, United States |
| Recall initiated | 2015-09-04 |
| Classified | 2015-10-16 |
| Reported by FDA | 2015-10-28 |
| Terminated | 2016-08-26 |
| 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; Orthosis, Spinal, Pedicle fixation Intended to provide immobilization and stabilization of spinal segments in skeletally mature patients.
Reason for recall
This product was produced using a finishing process not identified as part of the manufacturing specification. The process used with the lots subject to this Recall was a bead blast process. (Bead Blasting vs. Shot Peened).
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-0134-2016. 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.