Zimmer NexGen Option Stemmed Tibia Recalled for Sterility Concerns
Zimmer Manufacturing B.V. is recalling NexGen Option Stemmed Tibia components 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 is classified as FDA Class II, and the hazard involves a potential breach of sterility in an implantable medical device, which poses a risk of harm even without reported injuries.
Plain-English summary
Zimmer Manufacturing B.V. is recalling NexGen Option Stemmed Tibia components used in total knee arthroplasty. The recall affects 29,525 units distributed nationwide in the United States.
The recall was initiated because of insufficient sealer calibration data for products packaged in the firm's Building II between August 2010 and April 2013. The affected products are sterile, and the lack of calibration data raises concerns regarding the integrity of the sterile packaging.
Healthcare providers and patients should contact Zimmer Manufacturing B.V. for further information regarding the recall and potential replacement or repair options.
The recalled product
- Product
- Product 51 consists of all product under product code: JWH and same usage: Item no: 598603701 NEXGEN OPTION STEMMED TIB 598603702 NEXGEN OPTION STEMMED TIB 598604701 NEXGEN OPTION STEMMED TIB 598604702 NEXGEN OPTION STEMMED TIB 598605701 NEXGEN OPTION STEMMED TIB…
- Manufacturer
- Zimmer Manufacturing B.V.
- Hazard
- Affected units
- 29,525
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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