iFuse TORQ Implant System Model/Catalog Number: 10055T(10x55mm), 10060T(10x60mm), 10065T(10x65mm),
The pelvic fixation screws failed to meet acceptance criteria for tube packaging seal integrity testing; therefore, sterility assurance cannot be ensured.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
Severity not yet assessed
We have not scored this recall against our rubric yet, so we are not showing a severity rating or our usual guidance. The agency’s own notice below is the authoritative source — read it first.
Plain-English summary
The pelvic fixation screws failed to meet acceptance criteria for tube packaging seal integrity testing; therefore, sterility assurance cannot be ensured.
The recalled product
- Product
- iFuse TORQ Implant System Model/Catalog Number: 10055T(10x55mm), 10060T(10x60mm), 10065T(10x65mm), 10080T(10x55mm), 11580T(11.5x80mm)
- Manufacturer
- SI-BONE, Inc.
- Category
- Medical Device — Devices
- Affected units
- 100
Distribution
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