Si-bone recalls iFuse TORQ Implant System Model/Catalog Number: 10055T
FDAHome & Health recallNo official product photo was published for this recall.
What should I do?
Check whether you have this device (see the product and lot details below). If you do, stop using it and contact the company or your healthcare provider for next steps.
What's the hazard?
The pelvic fixation screws failed to meet acceptance criteria for tube packaging seal integrity testing; therefore, sterility assurance cannot be ensured.
What's affected
iFuse TORQ Implant System Model/Catalog Number: 10055T(10x55mm), 10060T(10x60mm), 10065T(10x65mm), 10080T(10x55mm), 11580T(11.5x80mm)
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