Recall Z-0034-2009 ยท GAR Suture, Nonabsorbable, Synthetic, Polyamide
Surgical Specialties Corp
3-0 Black Mono Nylon Suture, 12 units per box. product number 925B. The product intended for use in general soft tissue approximation and/or ligation including use in ophthalmic procedures.
| Date | Oct 2, 2008 (initiated Sep 9, 2008) |
| Status | Terminated |
| Reason | mislabeled product - labeled as 3-0 black mono nylon contains 4-0 black braided silk suture |
| Root cause | Employee error |
| Action | The recalling firm issued a Recall letter dated 9/9/08 to its customers. The letter informed the customers of the problem, the need to conduct a sub-recall, and return the product. Contact Surgical Specialties Corp. at 1-610-404-1000 for assistance. |
| Quantity | 956 boxes |
| Distribution | USA--AZ, CA, CT, FL, GA, IA, IL, KS, KY, LA, MD, MI, MS, NC, NJ, NY, OH, TN, TX, VA, and WA. OUS: Australia, Canada, and Fiji Islands. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K930825 | SUTURE NONABSORBABLE-NYLON,SILK,POLYESTER,STAINLES Surgical Specialties, Inc., Jan 7, 1994 |