Zimmer NexGen Knee System Recalled for Unapproved Component Combinations
Zimmer, Inc. is recalling NexGen Cruciate Retaining Complete Knee System components because surgeons are implanting unapproved combinations of micro and standard parts.
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 hazard involves the use of unapproved medical device combinations, which poses a risk of harm even though specific injuries are not detailed in the source text.
Plain-English summary
Zimmer, Inc. is recalling specific components of the NexGen Cruciate Retaining (CR) Complete Knee System. The recall involves 192,355 devices, including CR Micro Femurs, Articular Surfaces, Patellae, instruments, and provisionals. These devices are used in total knee arthroplasty and are indicated for patients with severe pain.
The recall is being conducted because surgeons are implanting the components in combinations that are not approved, specifically mixing micro components with standard components. A previous recall in March 2012 reiterated the proper combination labeling, but the mismatch problem has continued. The affected devices were distributed nationwide in the United States and in Japan.
Consumers and healthcare providers should stop using the affected devices and contact Zimmer, Inc. for further instructions on the recall.
The recalled product
- Product
- 00597604110 Articular Surface AC ART SURF 56/STRIPED GRN 10, Rx, Sterile; 00597604112 Articular Surface AC ART SURF 56/STRIPED GRN 12, Rx, Sterile; 00597604114 Articular Surface AC ART SURF 56/STRIPED GRN 14, Rx, Sterile; 00597604117 Articular Surface AC ART SURF 56/STRI
- Manufacturer
- Zimmer, Inc.
- Affected units
- 192,355
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 (1)
- all codes
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 47 recalled by Zimmer, Inc. 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 47 products in this recall →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 · unapproved combination
See all →- HighZimmer Recalls NexGen Knee System Components Due to Unapproved Combinations
FDA (Devices) · 2013-08-28
- HighZimmer Recalls NexGen Knee System Components Due to Unapproved Combinations
FDA (Devices) · 2013-08-28
- HighZimmer Recalls NexGen Knee System Components Due to Unapproved Combinations
FDA (Devices) · 2013-08-28
- HighZimmer Recalls NexGen Knee Components Due to Unapproved Combinations
FDA (Devices) · 2013-08-28
- HighZimmer Recalls NexGen Knee System Components Due to Unapproved Combinations
FDA (Devices) · 2013-08-28