Zimmer NexGen Taper Plug Recalled for Insufficient Sealer Calibration Data
Zimmer Manufacturing B.V. is recalling 1,767 NexGen Taper Plugs used in total knee arthroplasty due to insufficient sealer calibration data for products packaged between August 2010 and April 2013.
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. Per the rubric, risk-of-harm products where injury has not yet been reported are assigned a score of 3 (High).
Plain-English summary
Zimmer Manufacturing B.V. is recalling 1,767 units of the NexGen Taper Plug (Item no. 596009900), a medical device used in total knee arthroplasty. The recall affects products under product code JWH that were packaged in the firm's Building II between August 2010 and April 2013. The affected products are sterile.
The recall was initiated because of insufficient sealer calibration data for the affected lots. The source text does not specify the exact nature of the defect or any reported injuries or illnesses associated with the use of these devices.
The affected products were distributed nationwide in the United States. Consumers and healthcare providers should stop using the affected lots and contact Zimmer Manufacturing B.V. for further instructions or replacement.
The recalled product
- Product
- Product 54 consists of all product under product code: JWH and same usage: Item no: 596009900 NEXGEN TAPER PLUG for use in total knee arthroplasty
- Manufacturer
- Zimmer Manufacturing B.V.
- Affected units
- 1,767
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.
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