Zimmer Biomet Recalls Hip Arthroplasty Femoral Components Due to Packaging Defect
Zimmer Biomet is recalling 30 units of DELTA CER FEM HD 32/0MM T1 hip arthroplasty components because the sterile packaging may be melted upon opening.
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 hazard is a packaging defect (melted sterile packaging) without reported illnesses or injuries, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Zimmer Biomet, Inc. is recalling 30 units of DELTA CER FEM HD 32/0MM T1 femoral components intended for use in hip arthroplasty. The recall is due to the potential presence of melted sterile packaging upon opening. The affected product is identified by part number 650-1162 and lot number 2016030466.
The recall is classified as Class II by the U.S. Food and Drug Administration. The distribution was limited to the state of Texas. No specific dates or additional geographic details are provided in the source text.
Consumers and healthcare providers should stop using the affected product and contact Zimmer Biomet for further instructions. The source text does not report any illnesses or injuries associated with this recall.
The recalled product
- Product
- DELTA CER FEM HD 32/0MM T1 Product Usage: For use in hip arthroplasty
- Manufacturer
- Zimmer Biomet, Inc.
- Hazard
- Affected units
- 30
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 (1)
- part number: 650-1162 lot number: 2016030466
Distribution
Distributed in 1 state:
Part of a larger recall action
This product is one of 2 recalled by Zimmer Biomet, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 2 products in this recall →Related recalls
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