FDA Enforcement
Class II
Terminated
Sharpoint Polypropylene Blue Monofilament 6"/15cm 9-0 USP, Product No. J2558N
Recall: Z-2042-2016
·
Reported June 29, 2016
Enforcement
- Recall Number
- Z-2042-2016
- Event ID
- 74230
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- SSC- Surgical Specialties Corporation
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- June 29, 2016
- Initiation Date
- May 20, 2016
- Classification Date
- June 21, 2016
- Termination Date
- August 12, 2016
- Address
- 9993 Marconi Dr, N/A, San Diego, CA, 92154-7271, United States
Description
Sharpoint Polypropylene Blue Monofilament 6"/15cm 9-0 USP, Product No. J2558N
Reason
Surgical Specialties is recalling Sharpoint Polyproplyene Blue Monofilament 6"/15cm 9-0 USP because it may contain Black Nylon 9-0 suture.
Code Info
MAPX540
Distribution
TX, ME, MA, MI, OH, KS, MN, KS, TN, GA
Quantity
36 boxes (432 units)