Zimmer Trabecular Metal Hip Implant Shell Recalled for Missing Locking Ring
Zimmer, Inc. is recalling 17 units of Trabecular Metal Modular Acetabular System shells because the locking ring was missing.
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, and the defect (missing locking ring) is a component issue without reported injuries or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Zimmer, Inc. is recalling 17 units of the Trabecular Metal Modular Acetabular System, Shell with Cluster Holes, Porous 60mm (Catalog number 00-6202-060-22). The recall was initiated because the shell was missing the locking ring.
The affected units were distributed worldwide, including nationwide in the United States (specifically in GA, WI, NJ, CA, NY, NC, PA, FL, CT, ME, TX, and IL) and in Australia and Canada. The specific lot number is 62490588.
Healthcare providers and patients should check their inventory or medical records for this specific catalog number and lot number. If the product is identified, it should be removed from use and returned to the manufacturer or the FDA as directed.
The recalled product
- Product
- TRABECULAR METAL MODULAR ACETABULAR SYSTEM, Shell with Cluster Holes, Porous 60mm. Catalog number 00-6202-060-22; Hip implant component.
- Manufacturer
- Zimmer, Inc.
- Hazard
- Affected units
- 17
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)
- 00-6202-060-22
- lot 62490588
Distribution
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