Zimmer Biomet Recalls Custom Medical Devices Due to Packaging Adhesion
Zimmer Biomet is recalling 5.4 million custom medical devices because non-highly polished implants may adhere to the LDPE bag packaging.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a risk-of-harm product (medical device) where the hazard is physical adhesion, but no specific injuries or illnesses have been reported in the source text, fitting the 'High' criteria for risk-of-harm products without reported injury.
Plain-English summary
Zimmer Biomet, Inc. is recalling various custom medical devices, identified by specific item numbers, due to a packaging issue. The recall covers 5,459,583 total devices that were distributed nationwide. All affected products were manufactured prior to January 2014.
The recall is being issued because non-highly polished implants may adhere to the LDPE bag, which was the previous packaging configuration. This adhesion presents a potential risk during the handling or implantation of the devices.
Healthcare providers and patients who have received or are using these specific custom devices should contact Zimmer Biomet for further instructions on how to proceed. The company is responsible for managing the recall and providing guidance on the affected inventory.
The recalled product
- Product
- Various Custom Devices, Item Nos. 32855090246 32855090252 32855090256 32855090265 32855090266 32855090270 32855090287 32855090290 32855090291 32855090297 32855090302 32855090317 32855090318 32855090319 32855090327 32855090329 32855090334 32855090336 32855090339
- 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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