Ethicon, Inc.

Due a component mix-up in manufacturing, the affected products may contain incorrect needle type/size and suture length.

Complaints were received regarding needle pull-off and suture degradation. Analysis on returned product from this lot confirmed that some sutures were visually degraded in the package.

Issue on a specific packaging machine resulted in a hole in the primary packaging, product sterility compromised and could result in infection .

Issue on a specific packaging machine resulted in a hole in the primary packaging, product sterility compromised and could result in infection .

Issue on a specific packaging machine resulted in a hole in the primary packaging, product sterility compromised and could result in infection .

Issue on a specific packaging machine resulted in a hole in the primary packaging, product sterility compromised and could result in infection .

Issue on a specific packaging machine resulted in a hole in the primary packaging, product sterility compromised and could result in infection .

Issue on a specific packaging machine resulted in a hole in the primary packaging, product sterility compromised and could result in infection .

Some applicator tips from these lots had open seals.

Degraded and unusable upon removal from the foil pouch due to exposed environmental conditions during transit and storage, compromising sterility