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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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
- Manufacturer
- SSC- Surgical Specialties Corporation
- Category
- Medical Device — Surgical Suture
- Hazard
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
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