Zimmer Biomet Recalls Universal Locking Plates Due to Packaging Adhesion
Zimmer Biomet is recalling 5.4 million Universal 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, and the hazard involves a packaging defect (adhesion) without reported injuries or illnesses, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Zimmer Biomet, Inc. is recalling approximately 5,459,583 units of Universal Locking Plates Sterile. The recall affects all product manufactured prior to January 2014 and was distributed nationwide. The specific issue identified is that non-highly polished implants may adhere to the LDPE bag, which was the previous packaging configuration for these devices.
This recall is classified as Class II by the FDA. The hazard involves the physical interaction between the implant surface and the packaging material, which could potentially affect the handling or sterility of the device prior to use. No specific injuries or illnesses are reported in the source text.
Healthcare providers and facilities that have received these devices should check their inventory for the affected item numbers and manufacturing dates. They should stop using the affected products and contact Zimmer Biomet for instructions on return or replacement.
The recalled product
- Product
- Universal Locking Plates Sterile, Item Nos. 47492800207 47492800303 47492800402 47492800403 47492800407 47492800502 47492800503 47492800507 47492800603 47492800607 47492800613 47492800702 47492800703 47492800707 47492800802 47492800803 47492800807 47492800813…
- 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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