Zimmer Recalls VerSys Hip Stems Due to Material Inspection Failures
Zimmer, Inc. is recalling 147 VerSys Hip System stems because supplier forgings failed routine material inspections.
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 source text describes a failure to meet material specifications during routine inspection without reporting any illnesses, injuries, or deaths. This aligns with the rubric for moderate severity involving low-risk contamination or voluntary precautionary measures.
Plain-English summary
Zimmer, Inc. is recalling 147 units of VerSys Hip System, Beaded Fullcoat Stems. The recall was initiated after routine inspections revealed that beaded hip stem forgings received from a supplier failed to meet the required material specifications (ZES 2A-102). The affected products are CoCrMo Alloy Hip Stems processed according to specific material requirements.
The recalled stems were distributed nationwide in the United States and internationally to Canada, Colombia, the Dominican Republic, Japan, South Korea, Peru, Taiwan, and Thailand. Specific item numbers and lot numbers are listed in the official recall documentation.
Consumers and healthcare providers should stop using the affected hip stems and contact Zimmer, Inc. for further instructions. This recall is classified as Class II by the FDA, indicating a reasonable probability of temporary or medically reversible adverse health consequences.
The recalled product
- Product
- VerSys¿ Hip System, Beaded Fullcoat Stems, Zimmer, Inc., Warsaw, IN 46581
- Manufacturer
- Zimmer, Inc.
- Hazard
- Affected units
- 147
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 (20)
- Item # 784301108
- Lot #'s: 62478967
- 62479742
- 62503408
- 62528282
- 62530786
- 62544915
- 62554360
- Item # 784301126
- Lot #: 62544885
- 62547211
- Item # 784301156
- Lot #
- 62587079
- Item # 784301208
- Lot #'s: 62503411
- 62509385
- 62530790
- 62547217
- 62554362
Distribution
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