The Recall Desk
ModerateFDA (Devices)·Z-2042-2016·Announced 2016-06-29

Surgical Specialties Recalls Sharpoint Polypropylene Suture Due to Contamination

Surgical Specialties Corporation is recalling Sharpoint Polypropylene Blue Monofilament 9-0 USP suture because it may contain Black Nylon 9-0 suture.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, but the source text does not report any hospitalizations or injuries. It is a precautionary recall for a potential material mix-up without reported adverse health consequences.

Plain-English summary

Surgical Specialties Corporation is recalling Sharpoint Polypropylene Blue Monofilament 6"/15cm 9-0 USP, Product No. J2558N. The recall involves 36 boxes containing 432 units of the product.

The recall was initiated because the polypropylene suture may contain Black Nylon 9-0 suture. This is a potential mix-up of different suture materials.

The affected product was distributed to facilities in Texas, Maine, Massachusetts, Michigan, Ohio, Kansas, Minnesota, Tennessee, and Georgia. Healthcare providers and patients should check their inventory and discontinue use of the affected product.

The recalled product

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

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • MAPX540

Distribution

Distributed in 9 states:

Same manufacturer · SSC- Surgical Specialties Corporation

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