Recall Z-0146-2027
- Recall number
- Z-0146-2027
- Event number
- 99868
- Firm
- SI-BONE, Inc.
- Firm FEI
- 3007700286
- Product code
- OUR
- Status
- Open, Classified
- Initiated
- 2026-08-21
- Posted
- 2026-10-09
- Root cause
- Packaging
- 510(k) numbers
- K203247, K233508, K162733, K201538, K182983, K241574, K242141, K221047, K252834, K190580, K131405, K242431, K220195, K102907, K110838, K193524, K141549, K212962, K231923, K221050, K230857, K240505, K250894, K141049, K250247, K243838, K233241, K241464, K211785, K203503
Product#
iFuse TORQ Implant System Model/Catalog Number: 10055T(10x55mm), 10060T(10x60mm), 10065T(10x65mm), 10080T(10x55mm), 11580T(11.5x80mm)
Reason for Recall#
The pelvic fixation screws failed to meet acceptance criteria for tube packaging seal integrity testing; therefore, sterility assurance cannot be ensured.