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Recall Observatory FDA recall evidence

Device product

Sharpoint Polypropylene Blue Monofilament 6"/15cm 9-0 USP, Product No. J2558N

Z-2042-2016

May 20, 2016

Class II

Product summary

Firm
SSC- Surgical Specialties Corporation
Event
Event 74230
Status
Terminated
Classification
Class II
Quantity
36 boxes (432 units)
Official record key
device-enforcement:Z-2042-2016

Official wording

Reason: Surgical Specialties is recalling Sharpoint Polyproplyene Blue Monofilament 6"/15cm 9-0 USP because it may contain Black Nylon 9-0 suture.

Code information: MAPX540

Distribution pattern: TX, ME, MA, MI, OH, KS, MN, KS, TN, GA

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Surgical Specialties is recalling Sharpoint Polyproplyene Blue Monofilament 6"/15cm 9-0 USP because it may contain Black Nylon 9-0 suture.