Zimmer Biomet Recalls Metasul Head 40 Total Hip Prosthesis Components
Zimmer Biomet is recalling 194 Metasul Head 40 total hip prosthesis components because the packaging bag adheres to the 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, but the hazard is a packaging defect (bag adhesion) with no reported injuries or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Zimmer Biomet, Inc. is recalling 194 units of the Metasul Head 40, 12/14, SZ M/0 total hip prosthesis - metal femoral heads. The recall involves specific item number 00-8770-040-02 and seven distinct lot numbers. These medical devices are intended for use in total hip arthroplasty for patients with noninflammatory degenerative joint disease or inflammatory joint disease.
The recall was initiated because the LDPE bag containing the implant adheres to the highly polished implant surface. This packaging defect is the specific reason for the corrective action. The affected units were distributed worldwide, including nationwide in the United States and to numerous international locations.
Healthcare providers and patients who have received these specific hip prosthesis components should contact Zimmer Biomet for further instructions on how to proceed. The source text does not report any specific injuries or illnesses associated with this packaging issue.
The recalled product
- Product
- Metasul Head 40, 12/14, SZ M/0 total hip prosthesis - metal femoral heads Noninflammatory degenerative joint disease (NIDJD) including avascular necrosis, osteoarthritis, post-traumatic arthritis and congenital hip dysplasia and inflammatory joint disease (IJD) e.g. rheumatoid…
- Manufacturer
- Zimmer Biomet, Inc.
- Hazard
- Affected units
- 194
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.
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Similar recalls
- ModerateZimmer Recalls Metasul Head Implants Due to Packaging Adhesion Issue
FDA (Devices) · 2013-11-06
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