Zimmer Biomet Recalls Distal Lateral Femoral Locking Plates
Zimmer Biomet is recalling 5,459,583 sterile distal lateral femoral locking plates because non-highly polished implants may adhere to the packaging bag.
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. The hazard involves packaging adhesion rather than a direct structural failure or contamination, and no injuries or illnesses are reported in the source text, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Zimmer Biomet, Inc. is recalling 5,459,583 units of sterile distal lateral femoral locking plates. The affected products include specific item numbers and were distributed nationwide. All recalled devices were manufactured prior to January 2014.
The recall was initiated because non-highly polished implants may adhere to the low-density polyethylene (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 facilities that have received these devices should stop using them and contact Zimmer Biomet for instructions on return or replacement. Consumers should not use these medical devices if they have them in their possession.
The recalled product
- Product
- DIST LAT FEM LCK PLATE STERILE, Item Nos. 47235710106 47235710110 47235710114 47235710118 47235710122 47235710210 47235710214 47235710218 47235710222
- 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 product 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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