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.
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 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 arthr
- 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
Related recalls
Same manufacturer · Zimmer, Inc.
See all →- HighZimmer Off-Axis Alliance Glenoid Reamer Guide recalled for breakage
FDA (Devices) · 2026-07-01
- ModerateZimmer Shoulder System Reamer Guide recalled for plastic breakage
FDA (Devices) · 2026-07-01
- ModeratePersona Revision Trabecular Metal Femoral Distal Augment recalled for packaging defect
FDA (Devices) · 2026-07-01
- HighZimmer Shoulder Reamer Guide System Recalled for Plastic Breakage
FDA (Devices) · 2026-07-01
- HighZimmer Off-Axis Alliance Glenoid Reamer Guide Plastic Breakage Recall
FDA (Devices) · 2026-07-01
Same hazard · mechanical failure
See all →- HighIMRIS ORT300 Operating Room Table Recalled for Mechanical Failure Risk
FDA (Devices) · 2026-09-02
- HighIMRIS ORT200 Operating Room Table Recalled for Mechanical Failure Risk
FDA (Devices) · 2026-09-02
- HighForest River Transit Buses Recalled for Wheelchair Lift Control Failure
NHTSA · 2026-09-01
- HighBlue Bird Recalls Vision School Buses Due to Wheelchair Lift Defect
NHTSA · 2026-08-31
- SevereMagic Tilt Watercraft Trailers Recalled Due to Winch Weld Failure
NHTSA · 2026-08-28