Recall Z-2042-2016 ยท GAW Suture, Nonabsorbable, Synthetic, Polypropylene
SSC- Surgical Specialties Corporation
Sharpoint Polypropylene Blue Monofilament 6"/15cm 9-0 USP, Product No. J2558N
| Date | May 20, 2016 |
| Status | Terminated |
| Reason | Surgical Specialties is recalling Sharpoint Polyproplyene Blue Monofilament 6"/15cm 9-0 USP because it may contain Black Nylon 9-0 suture. |
| Root cause | Process control |
| Action | A customer notification letter dated 5/20/16 was sent to all customers to inform them that Surgical Specialties is recalling Sharpoint Polyproplyene Blue Monofilament 6"/15cm 9-0 USP because it may contain Black Nylon 9-0 suture. Customers are instructed to complete the attached customer acknowledgement form and return via fax to Surgical Specialties' Quality Assurance department at (610) 404-4010 or return via email to kknappenberger@surgicalspecialties.com. Customers with any questions are instructed to contact Kelly Knappenberger at (484) 220-2402 or Kris Liberacki at (262) 994-8083. |
| Quantity | 36 boxes (432 units) |
| Distribution | TX, ME, MA, MI, OH, KS, MN, KS, TN, GA |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K904906 | SHARPOINT POLYPROPYLENE NONABSORB SURG SUTURES USP Chathamborough Research Group, Inc., Dec 24, 1990 |