Zimmer Recalls NexGen Knee Components Due to Stem Locking Failure
Zimmer, Inc. is recalling 128 NexGen Complete Knee Solutions Stemmed Tibial Components because the stem may not lock into the tibia.
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 source text describes a mechanical defect (stem not locking) that poses a risk of harm to patients, but no injuries or illnesses are explicitly reported in the provided text.
Plain-English summary
Zimmer, Inc. is recalling 128 units of the NexGen Complete Knee Solutions Stemmed Tibial Component Precoat. These devices are part of the NexGen systems of semi-constrained, non-linked condylar knee prosthesis, indicated for patients with severe knee pain and disability due to conditions such as rheumatoid arthritis, osteoarthritis, and traumatic arthritis.
The recall was initiated after two complaints were received reporting that the stem would not lock into the tibia. Evaluation of the returned device revealed that the stemmed portion of the tibial plate would not hold the stem because the connection was too loose. Specifically, the taper diameter was found to be oversized by .010.
The affected units were distributed worldwide, including nationwide in the United States and in China, Japan, and Taiwan. The specific lot number is 6228417, and the code is 00-5980-037-02. Consumers and healthcare providers should contact Zimmer, Inc. for further instructions regarding the return or replacement of these devices.
The recalled product
- Product
- NexGen¿ Complete Knee Solutions Stemmed Tibial Component Precoat NexGen Tibial Baseplates are part of the NexGen systems of semi-constrained, non-linked condylar knee prosthesis. The device is indicated for patients with severe knee pain and disability due to: Rheumatoid…
- Manufacturer
- Zimmer, Inc.
- Hazard
- Affected units
- 128
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 (2)
- 00-5980-037-02
- lot 6228417
Distribution
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