SPEEDSHIFT20x20x20 Offset 10mm Implant Drill Kit — Class II medical device recall Z-0098-2023
Ongoing recall by Synthes (USA) Products LLC, reported 2022-10-26, distributed nationwide. The subject products are being recalled because they contain the incorrect size drill guide and will not prepa
| Recall number | Z-0098-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Synthes (USA) Products LLC, West Chester, PA, United States |
| Recall initiated | 2022-09-27 |
| Classified | 2022-10-18 |
| Reported by FDA | 2022-10-26 |
| Distributed | Nationwide (US) |
| Quantity | 81 |
| Reason classes | sterility |
| UPC / GTIN / UDI-DI | 00810633020494 |
| Lot numbers | MSE210237 |
| Expiration dates | 2026-11-01 |
Product
SPEEDSHIFT20x20x20 Offset 10mm Implant Drill Kit, Product No. SE-2020-10. Used with DePuy Synthes SPEEDSHIFT Continuous Compression Staple Implants for bone fixation and management of fracture and reconstructive surgery.
Reason for recall
The subject products are being recalled because they contain the incorrect size drill guide and will not prepare the bone correctly for the size of the implant included in the sterile kit. If the incorrect drill guide is used, there is potential for bone damage due to incorrectly placed drill holes for the implant included in the kit.
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-0098-2023. 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.