Zimmer Recalls Persona Knee System Female Screws Due to Stripping Risk
Zimmer, Inc. is recalling 16,380 units of Persona The Personalized Knee System 2.5 mm Female Screws due to potential stripping of the hex driver when used in cortical bone.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a mechanical failure (driver stripping) during a surgical procedure, which poses a risk of harm even though specific injuries are not reported in the source text.
Plain-English summary
Zimmer, Inc. is recalling 16,380 units of the Persona The Personalized Knee System 2.5 mm Female Screw, 48 mm Length, Sterile, Qty-2. The product is sterilized using irradiation and is intended for single use.
The recall is being conducted because the screw may be used in cortical bone, which can cause the 2.5 mm Persona Hex Driver to strip. The affected lots were distributed nationwide to 40 states and internationally to Singapore, Japan, Germany, and Canada.
Healthcare providers and facilities should check their inventory for the specific lot numbers listed in the recall notice. If the product is found, it should be removed from use and returned to Zimmer, Inc. in accordance with the recall instructions.
The recalled product
- Product
- Persona The Personalized Knee System 2.5 mm Female Screw 48 mm Length Sterile Qty-2. Sterilized using irradiation, single use.
- Manufacturer
- Zimmer, Inc.
- Affected units
- 16,380
Distribution
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