Recall Z-0492-2015 ยท GAP Suture, Nonabsorbable, Silk
Ethicon, Inc.
Ethicon PERMA-HAND Silk siliconized black braided 10 strands per packet Ethicon LLC- Made in USA.
| Date | Jan 9, 2015 (initiated Oct 17, 2014) |
| Status | Terminated |
| Reason | Ethicon is unable to ensure that PERMA-HAND silk suture (siliconized black braid) meets the expected sterility assurance level for sterile products. |
| Root cause | Other |
| Action | Ethicon sent an Urgent Medical Device Recall Letter/Business Reply Form dated 10/17/2014 via UPS next day mail. |
| Quantity | 2,508 each |
| Distribution | Nationwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K946173 | STAINLESS STEEL, GUT, POLY (GLYCOLIDE/L-LACTIDE) POLYAMIDE, POLYPROPYLENE, POLY (ETHYLENE TEREPHTHALATE) AND SILK ETHICON, Inc., Jan 9, 1995 |