Zimmer NexGen Osteotomy Cortical Bone Screws Recalled for Sterility Concerns
Zimmer Manufacturing B.V. is recalling NexGen Osteotomy Cortical Bone Screws due to insufficient sealer calibration data, raising concerns about the sterility of the devices.
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 3/5 (High).
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 (sterile medical device) where injury has not yet been reported, fitting the High severity criteria for theoretical risk of infection or contamination.
Plain-English summary
Zimmer Manufacturing B.V. is recalling 925 units of NexGen Osteotomy Cortical Bone Screws (Product 52, Product Code HWC) used in total knee arthroplasty. The recall is due to insufficient sealer calibration data for products packaged in the firm's Building II between August 2010 and April 2013.
The affected products are sterile. The recall covers specific lot numbers including 61996176, 61996176N, 61996177, 61996177N, 61687334, 61926537, 62308501, 61811187, 61996179, and 61996179N. The products were distributed nationwide in the United States.
Healthcare providers and patients should check their inventory and patient records for these specific lot numbers. If the devices have been implanted, providers should contact Zimmer Manufacturing B.V. for further instructions on monitoring or removal.
The recalled product
- Product
- Product 52 consists of product code: HWC and same usage: Item no: 525004530 NEXGEN OSTEOTOMY CORT BON 525004540 NEXGEN OSTEOTOMY CORT BON 525006545 NEXGEN OSTEOTOMY CORT BON 525006560 NEXGEN OSTEOTOMY CORT BON 525006565 NEXGEN OSTEOTOMY CORT BON for use in total knee…
- Manufacturer
- Zimmer Manufacturing B.V.
- Affected units
- 925
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 72 recalled by Zimmer Manufacturing B.V. 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 72 products in this recall →Related recalls
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