Zimmer Segmental System Hip Stem Recalled for Coating Defect
Zimmer, Inc. is recalling specific Zimmer Segmental System hip stems because the PMMA coating may be missing or not meet specifications.
What this means for you
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 source text describes a manufacturing specification defect (missing coating) without reporting any injuries, illnesses, or deaths. This aligns with the rubric for moderate severity involving low-risk contamination or voluntary precautionary recalls where harm has not been reported.
Plain-English summary
Zimmer, Inc. is recalling the Zimmer Segmental System (ZSS) Cemented Stem and ZSS Cemented Stem, Smooth Stem Prosthesis. The recall involves a hip prosthesis made of metal, ceramic, and polymer materials. The specific item number is 00-5852-052-10 and the lot number is 62866438.
The recall was initiated because the PMMA coating on the stem does not meet specifications. Specifically, the area of the stem may be missing the PMMA coating. This defect could affect the performance of the implant.
The affected units were distributed in the United States to the state of Texas. Healthcare providers and patients who have received this specific implant should contact their healthcare provider or Zimmer, Inc. for further instructions on how to proceed.
The recalled product
- Product
- Zimmer Segmental System (ZSS) Cemented Stem / ZSS Cemented Stem, Smooth Stem Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented or Non-Porous, Uncemented.
- Manufacturer
- Zimmer, Inc.
- Affected units
- 1
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)
- Item No. 00-5852-052-10
- Lot 62866438
Distribution
Distributed in 1 state:
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