Integra LifeSciences Recalls METASURG Capture Screw System K-wires
Integra LifeSciences is recalling 182 K-wires used in the METASURG Capture Screw System because they do not meet material, surface, and dimensional specifications.
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, injuries, or illnesses, fitting the criteria for a moderate severity score.
Plain-English summary
Integra LifeSciences Corp. is recalling 182 units of the K-wire, Smooth Double-pointed 0.8 x 90mm, which is a component of the METASURG Capture Screw System. The affected K-wires are used by physicians to insert into bone to act as a guide for drilling, countersinking, and installing 2.0 mm cannulated screws.
The recall was initiated because the affected K-wires do not meet specification requirements. Specifically, the K-wires were made of 316LVM stainless steel instead of the required 304 stainless steel, they have a passivated surface finish instead of an electro-polish surface finish, and they have incorrect length and diameter.
The affected units are from Lot 237830TE. The products were distributed nationwide to Oklahoma, California, Texas, Washington, Georgia, New York, Mississippi, and Pennsylvania. The source text does not specify the actions consumers or healthcare providers should take.
The recalled product
- Product
- K-wire, Smooth Double-pointed 0.8 x 90mm, a component of the METASURG Capture Screw System The K-wire is used in conjunction with the 2.0 mm cannulated screws for the METASURG Capture Screw System. The K-wire is used by the physician to insert into the bone and to act as a…
- Manufacturer
- Integra LifeSciences Corp.
- Affected units
- 182
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)
- Lot 237830TE
Distribution
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