Suture, Absorbable, Synthetic, Polyglycolic Acid

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 .

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

Packages may contain a PS-1 cutting edge needle and not the intended SH taper point needle may result in more tissue trauma than is anticipated for taper point needles, which may necessitate repair

Some sutures in the lot may exhibit a small section of braid fraying, which can lead to reduced tensile strength at that point.

Channels in the packaging seal that can lead to suture degradation and loss of packaging integrity. Recall Z-0021-2009 was initiated in 2008. Ethicon had decided to recall all sutures product during the may to June 2007 timeframe.

Sterility Issue: The firm decided to remove the product because it cannot assure the sterility of the products due to a failure in the sterilization process.