All Recalls

Potential for the outer bag having pinhole leaks near the seal, which may result in a breach in the sterility of the kit.

Potential for the outer bag having pinhole leaks near the seal, which may result in a breach in the sterility of the kit.

Specific lots of FLXfit implants have internal components that may have been manufactured using stainless steel rather than the specified titanium alloy.

Potential for the outer bag having pinhole leaks near the seal, which may result in a breach in the sterility of the kit.

Potential for the outer bag having pinhole leaks near the seal, which may result in a breach in the sterility of the kit.

Potential for the outer bag having pinhole leaks near the seal, which may result in a breach in the sterility of the kit.

Software anomalies, CP App messages: "Too Many Device Found", "Unexpected Device Error Code 1502", and "System Update Needed, Service Code 303"

There is a potential leaking condition within the hub of affected devices, due to an inter-lumen void in the hub component, which may result in unanticipated fluid return during use.

Complaints of leaking packets were received.

Software anomalies, CP App messages: "Too Many Device Found", "Unexpected Device Error Code 1502", and "System Update Needed, Service Code 303"

Integra LifeSciences identified that one lot was released with out-of-specification endotoxin results. The worst-case risk for the use of affected Surgical Patties is potentially a minor transient fever.

Ball bearings in the CRANI-A (ANSPACH Power Tools Adult Craniotome Attachment) came out of the attachment, possibly during removal of the attachment, intra-operatively. Failure to follow the recommended inspection intervals provided in the IFU may result in serious patient injury

Potential for the outer bag having pinhole leaks near the seal, which may result in a breach in the sterility of the kit.

Potential for the outer bag having pinhole leaks near the seal, which may result in a breach in the sterility of the kit.

Software anomalies, CP App messages: "Too Many Device Found", "Unexpected Device Error Code 1502", and "System Update Needed, Service Code 303"

Potential for the outer bag having pinhole leaks near the seal, which may result in a breach in the sterility of the kit.

Potential for the outer bag having pinhole leaks near the seal, which may result in a breach in the sterility of the kit.

Potential for the outer bag having pinhole leaks near the seal, which may result in a breach in the sterility of the kit.

Potential for the outer bag having pinhole leaks near the seal, which may result in a breach in the sterility of the kit.

Blister package had an unsealed edge compromising sterility.