Zimmer Biomet Recalls THP Hip Plating System Due to Fracture Risk
Zimmer Biomet is recalling 1,662 units of the THP Hip Plating System after internal testing detected a potential increase in fracture rate and packaging discoloration.
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 involves a risk-of-harm product (increased fracture rate) where injury has not yet been reported, which aligns with the 'High' severity criteria for medical devices.
Plain-English summary
Zimmer Biomet, Inc. is recalling 1,662 units of the THP Hip Plating System, a metallic bone fixation device. The recall was initiated after internal testing detected a potential increase in the fracture rate of the device. Additionally, potential discoloration was observed inside the inner pouch of the product packaging.
The affected product includes specific item numbers ranging from 14-451070 to 14-451130. The recall covers numerous specific lot numbers, including 397440, 875130, and 018810, among others. The devices were distributed domestically to 21 states, including Alabama, California, Florida, and Texas.
Patients who have had this device implanted should contact their healthcare provider for guidance. The source text does not specify a direct action for consumers who have not yet had the device implanted, but the recall is active for the identified lots and item numbers.
The recalled product
- Product
- THP Hip Plating System, Item Nos. 14-451070 14-451075 14-451080 14-451085 14-451090 14-451095 14-451100 14-451105 14-451110 14-451115 14-451120 14-451125 14-451130 . The product is a metallic bone fixation system.
- Manufacturer
- Zimmer Biomet, Inc.
- Hazard
- Affected units
- 1,662
Distribution
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