3 — Class II medical device recall Z-1711-2015
Terminated recall by Synthes, Inc., reported 2015-06-10, distributed nationwide. affected parts and lots of the Cannulated Drill Bits have the potential to break during use
| Recall number | Z-1711-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Synthes, Inc., West Chester, PA, United States |
| Recall initiated | 2015-05-13 |
| Classified | 2015-06-04 |
| Reported by FDA | 2015-06-10 |
| Terminated | 2016-08-18 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA |
| Reason classes | device malfunction |
| Lot numbers | PE00959, PE00966, PE00968, PE00971, PE00974, PE00998, PE01000, PE01006, PE01011, PE01039, PE01040, PE01048, PE01058, PE01059 |
| Model numbers | 310.221, 310.65, 310.67 |
Product
3.2 mm Cannulated Drill Bit/ QC 170 mm 2.7 Cannulated Drill Bit/ QC 160 mm 2.0 mm Cannulated Drill Bit / QC 150 mm there is no indication for Synthes Cannulated Drill Bits which is used with the Synthes Cannulated Screw. The Synthes Cannulated Screw, used with the threaded washer, is generally intended for intra-articular fixation of small bones, such as the hand, wrist, and forefoot.
Reason for recall
affected parts and lots of the Cannulated Drill Bits have the potential to break during use
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-1711-2015. 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.