Zimmer Biomet Recalls Temporary Surgical Devices Due to Packaging Adhesion
Zimmer Biomet is recalling 5.4 million temporary surgical devices 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, but the source text does not report any hospitalizations, injuries, or illnesses. The hazard is a packaging adhesion issue, which fits the criteria for a moderate severity rating involving low-risk contamination or voluntary precautionary measures without reported harm.
Plain-English summary
Zimmer Biomet, Inc. is recalling various temporary devices used during the implantation of a device system. The affected items include bone fixation plates and screws, drill bits, and manual surgical instruments for general use. The recall covers 5,459,583 total devices that were distributed nationwide.
The recall is being conducted because non-highly polished implants may adhere to the LDPE bag, which was the previous packaging configuration. The source text does not report any specific illnesses, injuries, or deaths associated with this issue.
Healthcare providers and consumers should stop using the affected devices. The recall applies to all products manufactured prior to January 2014. Specific item numbers involved in the recall include 0202024301, 0202024325, 0202024330, 0202024342, 0202024344, 0202024346, 0202024360, 0202024362, and 47225806700.
The recalled product
- Product
- Various temporary devices used during the implantation of the device system: bone fixation plates and screws, drill bits, manual surgical instruments for general use. Item Nos. 0202024301 0202024325 0202024330 0202024342 0202024344 0202024346 0202024360 0202024362…
- 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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