Zimmer Recalls Hip Stems Due to Sterile Barrier Integrity Testing
Zimmer, Inc. is recalling VerSys Hip System femoral stems because historic packaging validations indicated a need for additional testing to ensure sterile barrier integrity.
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: This is a voluntary precautionary recall to verify sterile barrier integrity based on historic packaging validations, with no reported illnesses or injuries, fitting the criteria for a moderate severity score.
Plain-English summary
Zimmer, Inc. is recalling VerSys Cemented Revision Calcar (CRC) Hip System Femoral Stems and VerSys Heritage Hip System Revision Femoral Stems. These medical devices are indicated for total hip arthroplasty. The recall involves 12,866 units that were distributed worldwide, including the United States (nationwide, Puerto Rico, and Virgin Islands) and numerous international countries.
The recall was initiated following a review of historic packaging validations. Zimmer determined that a subset of product packaged in one of the clean rooms at a single facility required testing to ensure that previously packaged product met established requirements for sterile barrier integrity. Specifically, the company is conducting packaging testing for seal integrity and seal strength.
Patients who have had these devices implanted should contact their healthcare provider for guidance. The source text does not report any illnesses or injuries associated with this recall.
The recalled product
- Product
- VerSys¿ Cemented Revision Calcar (CRC) Hip System Femoral Stems VerSys Heritage Hip System Revision Femoral Stems. Indicated for total hip arthroplasty.
- Manufacturer
- Zimmer, Inc.
- Affected units
- 12,866
Distribution
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