Zimmer Biomet Recalls Metasul Taper Liners Due to Packaging Adhesion
Zimmer Biomet is recalling Metasul Taper Liners because non-highly polished implants may adhere to the LDPE bag. The recall covers devices manufactured prior to January 2014.
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 involves a packaging defect (adhesion) without reported injuries or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Zimmer Biomet, Inc. is recalling Metasul Taper Liners in various sizes. The recall involves 5,459,583 total devices that were distributed nationwide. The affected products are all items manufactured prior to January 2014.
The reason for the recall is that non-highly polished implants may adhere to the LDPE bag, which was the previous packaging configuration. This issue is specific to the packaging and the surface finish of the implants.
Healthcare providers and patients should check their inventory for these specific item numbers and manufacturing dates. If the devices are found, they should be removed from use and returned to the manufacturer or disposed of according to local regulations.
The recalled product
- Product
- Metasul Taper Liner, various sizes, Item Nos. 00877000528 00877000628 00877000732 00877000832 00877000936 00877001036 00877001140 00877001240 00877001340 00877001440 00877001540 00877001640 00877001740 00877001840 00877001940 00877002040 00877002140 00877002240…
- Manufacturer
- Zimmer Biomet, Inc.
- Hazard
- Affected units
- 5,459,583
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)
- All products manufactured prior to January 2014.
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 41 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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