SSS Reprocessed Zimmer — Class II medical device recall Z-0235-2016
Terminated recall by Stryker Sustainability Solutions, reported 2015-11-18, distributed nationwide. It was reported that packaging was not properly sealed.
| Recall number | Z-0235-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Stryker Sustainability Solutions, Tempe, AZ, United States |
| Recall initiated | 2015-10-14 |
| Classified | 2015-11-06 |
| Reported by FDA | 2015-11-18 |
| Terminated | 2016-05-06 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA |
| Quantity | 1,202 |
| Lot numbers | 3743743, 3750611, 3750630, 3753894, 3761982, 3775827, 3779058, 3779129, 3782549, 3782554, 3782565, 3785624, 3785630, 3785676, 3789092, 3789102, 3794000, 3794085, 3796706, 3796799, 3799827, 3802103 |
| Model numbers | 2108-109, 2108-110, 2108-115, 2108-120, 2108-151-001, 2108-152, 2108-158, 2108-182, 2108-218, 310.25, 4118-127-090, 4125-127-090, 4125-147-090, 4806-110-25, 5071-553, 6118-127-90, 6125-127-090 |
Product
SSS Reprocessed Zimmer, Synthes, Stryker and Linvatec Drill Bits and Blades Surgical drill bits, blades, burs, chisels, rasps, taps and reamers are specially designed surgical accessories to help the surgeon cut and drill bone and bony structures. Reprocessed surgical accessories are indicated for use in patients requiring surgery involving bone and bony structures.
Reason for recall
It was reported that packaging was not properly sealed.
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-0235-2016. 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.