Zimmer Biomet Recalls Bipolar Shell Hip Prostheses Due to Packaging Defect
Zimmer Biomet is recalling 72,806 Bipolar Shell hip prostheses because the LDPE packaging bag adheres to the polished implant surface.
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 (adhesion) rather than a direct structural failure or contamination, fitting the Moderate criteria for low-risk issues.
Plain-English summary
Zimmer Biomet, Inc. is recalling 72,806 units of the Bipolar Shell prosthesis, a semi-constrained hip implant made of metal, ceramic, and polymer. The recall is due to a defect where the LDPE bag containing the implant adheres to the highly polished implant surface.
The affected products were distributed worldwide, including nationwide in the United States and to numerous international locations. The recall covers various sizes of the implant, identified by specific item numbers and lot numbers listed in the agency record.
Consumers and healthcare providers should stop using the affected implants and contact Zimmer Biomet for further instructions on how to proceed with the recall.
The recalled product
- Product
- Bipolar Shell prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented various sizes Use of the MultiPolar Bipolar Cup is indicated in: Fracture dislocation of the hip. Elderly, debilitated patients when a total hip replacement is…
- Manufacturer
- Zimmer Biomet, Inc.
- Hazard
- Affected units
- 72,806
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 21 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 21 products in this recall →Related recalls
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Similar recalls
- HighZimmer Biomet Recalls Hip and Knee Implants Due to Packaging Residue
FDA (Devices) · 2018-03-21
- ModerateZimmer Multipolar Bipolar Cup Metal Shell Recall Due to Packaging Adhesion
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