FDA Device recall Z-0100-2023
SPEED 9X10X10mm Continuous Compression Implant, Product No. SE-0910
- FDA Device
- Class II
- ongoing
- Published 2022-10-26
On 2022-10-26 the FDA classified a Class II recall of SPEED 9X10X10mm Continuous Compression Implant, Product No. SE-0910 by Synthes Usa Products, citing 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 ste….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0100-2023 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2022-09-27 |
| Published | 2022-10-26 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Synthes Usa Products |
| Distribution | US |
Product
SPEED 9X10X10mm Continuous Compression Implant, Product No. SE-0910
Reason
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.
Identifiers
| code_info | UDI-DI (GTIN): 00810633020111 Lot/Expiry MSE210240 7/1/2027 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Other recalls by Synthes Usa Products
- 2.4 VOLT TAP LOCKING SCREW TAP TO 90MM. Part Number: 03.424.124-US
FDA Device · Class II · 2026-04-08 · Synthes Usa Products - 2.4 VOLT(TM) TAP CORTEX SCREW TO 90MM. Part Number: 03.424.126-US
FDA Device · Class II · 2026-04-08 · Synthes Usa Products - LOW PROF LCKNG SCREW, F/IM NAIL 5.0MM / L, 46MM / XL25/ STER. Product Code: 04.045.346TS. Used in RFN-ADVANCEDTM Retrograde Femoral Nailing…
FDA Device · Class II · 2025-10-29 · Synthes Usa Products - LOW PROF LCKNG SCREW, F/IM NAIL 5.0MM / L, 42MM / XL25/ STER. Product Code: 04.045.342TS. Used in RFN-ADVANCEDTM Retrograde Femoral Nailing…
FDA Device · Class II · 2025-10-29 · Synthes Usa Products - STARDRIVE SCRWDRVR SHFT/T4 50MM/SELF-RETAINING/HXC-Intended for tightening, loosening, or removing of screw implants during orthopaedic sur…
FDA Device · Class II · 2024-06-05 · Synthes Usa Products
All Synthes Usa Products recalls
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0100-2023%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.