Recall Z-2042-2016
SSC- Surgical Specialties Corporation · initiated May 20, 2016
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Sharpoint Polypropylene Blue Monofilament 6"/15cm 9-0 USP, Product No. J2558N
Codes / lots: MAPX540
Reason for recall
Surgical Specialties is recalling Sharpoint Polyproplyene Blue Monofilament 6"/15cm 9-0 USP because it may contain Black Nylon 9-0 suture.
FDA-determined cause: Process control
Action taken
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.
Details
- Recall number
- Z-2042-2016
- Initiated
- May 20, 2016
- Terminated
- August 12, 2016
- Product code
- GAW – Suture, Nonabsorbable, Synthetic, Polypropylene
- Quantity
- 36 boxes (432 units)
- Distribution
- TX, ME, MA, MI, OH, KS, MN, KS, TN, GA
- Recalling firm
- SSC- Surgical Specialties Corporation, San Diego, CA