Zimmer Recalls 19 Hip Prosthesis Shells Due to Missing Threads
Zimmer, Inc. is recalling 19 Continuum Acetabular System hip prosthesis shells because they are missing polar boss threads.
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 medical device with a structural defect (missing threads) that poses a risk of harm, but the source text does not report any specific injuries or illnesses, aligning with the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Zimmer, Inc. is recalling 19 units of the Continuum Acetabular System Trabecular Metal Shell with Multi Holes, Porous 68mm, Prosthesis, Hip, Semi-Constrained, Metal/Polymer. The recall is being conducted because the affected products are missing polar boss threads.
The affected units are identified by Part Number 00-8757-068-02 and Lot Number 62207029. These products were distributed nationwide in the United States to the states of Iowa, California, North Carolina, Alabama, Washington, Florida, Tennessee, Massachusetts, Arizona, Texas, Utah, and Nevada, as well as internationally to Japan.
Healthcare providers and patients should contact Zimmer, Inc. for further instructions regarding the return or replacement of these devices.
The recalled product
- Product
- Continuum Acetabular System Trabecular Metal Shell with Multi Holes, Porous 68mm, Prosthesis, Hip, Semi-Constrained, Metal/Polymer
- Manufacturer
- Zimmer, Inc.
- Hazard
- Affected units
- 19
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 (2)
- Part Number: 00-8757-068-02
- Lot Number: 62207029
Distribution
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