Si-bone, Inc.: Sacroiliac Joint Fixation
Recall Summary SI-BONE, Inc. is recalling specific models of iFuse TORQ Implant System sacroiliac joint fixation screws because the packaging seals failed integrity testing, meaning sterility cannot be guaranteed. The affected products were distributed nationwide to hospitals and surgical facilities. Patients who received these implants between specific dates should contact their healthcare provider to determine if they were affected.
- Recalling firm
- SI-BONE, Inc.
- Product
- iFuse TORQ Implant System Model/Catalog Number: 10055T(10x55mm), 10060T(10x60mm), 10065T(10x65mm), 10080T(10x55mm), 11580T(11.5x80mm)
- Reason
- The pelvic fixation screws failed to meet acceptance criteria for tube packaging seal integrity testing; therefore, sterility assurance cannot be ensured.
- Classification
- Class II
- Category
- medical device recall
- Country
- United States
- Agency
- FDA-DEVICES
- Recall date
- 2026-08-21
- Status
- Open, Classified
- Areas affected
- AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
- Distribution
- US Nationwide distribution in the states of FL, GA, HI, NC, OH, PA, SD, TX, VA.
Official recall notice from FDA-DEVICES
Recall details on Nibble Recalls: https://trynibble.app/recalls/fe1d7026-96b9-43af-990b-be2284f63e2e