Zimmer Biomet Recalls Limb Salvage Arthroplasty Devices Due to Packaging Issue
Zimmer Biomet is recalling 5,459,583 limb salvage arthroplasty devices because non-highly polished implants may adhere to the LDPE bag packaging.
What this means for you
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 issue where implants may adhere to the bag. There are no reports of injuries or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Zimmer Biomet, Inc. is recalling various devices for limb salvage arthroplasty. The recall involves 5,459,583 total devices distributed nationwide. The affected products include specific item numbers listed in the recall notice and were all 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 could potentially affect the handling or integrity of the devices.
Healthcare providers and patients who have received these devices should contact Zimmer Biomet for further instructions on how to proceed. The company is responsible for managing the recall and providing necessary support to affected parties.
The recalled product
- Product
- Various Devices for Limb salvage arthroplasty, Item Nos. 00585000011 00585001201 00585001202 00585001301 00585001302 00585003038 00585003214 00585003217 00585003219 00585003238 00585003246 00585004445 00585004455 00585004465 00585004603 00585004604 00585004605 00
- 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.
See all 41 products in this recall →Related recalls
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