Zimmer Recalls NexGen Knee System Components Due to Unapproved Combinations
Zimmer, Inc. is recalling NexGen Cruciate Retaining Knee System components because surgeons are implanting unapproved combinations of micro and standard parts.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II, which corresponds to a 'Severe' severity score under the rubric, particularly given the context of a structural implant defect.
Plain-English summary
Zimmer, Inc. is recalling 192,355 units of the NexGen Cruciate Retaining (CR) Complete Knee System, including CR Micro Femurs, Articular Surface, Patellae, instruments, and provisionals. The recall is being conducted because surgeons are implanting these components in combinations that are not approved, specifically mixing micro components with standard components.
The affected devices are used in total knee arthroplasty and are indicated for patients with severe pain. The distribution pattern includes nationwide distribution in the United States and the country of Japan. A previous recall in March 2012 reiterated the proper combination labeling, but the mismatch problem has continued.
Consumers and healthcare providers should contact Zimmer, Inc. for further information regarding the recall and proper device usage.
The recalled product
- Product
- 00597502010 Provisional AC ART SURF PROV 12/PUR 10, Rx, Sterile; 00597502012 Provisional AC ART SURF PROV 12/PUR 12, Rx, Sterile; 00597502014 Provisional AC ART SURF PROV 12/PUR 14, Rx, Sterile; 00597502017 Provisional AC ART SURF PROV 12/PUR 17, Rx, Sterile…
- 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 Plastic Breakage Recall
FDA (Devices) · 2026-07-01
- HighZimmer Off-Axis Alliance Glenoid Reamer Guide recalled for breakage
FDA (Devices) · 2026-07-01
- HighZimmer Shoulder Reamer Guide System 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 Off-Axis Comprehensive Shoulder System Reamer Guide Recall
FDA (Devices) · 2026-07-01
Same hazard · mis labeling
See all →- SevereWhite Vein Advanced Alkaloids Chewable Tablets Recall for Excess Active Ingredient
FDA (Food) · 2026-10-14
- SevereBetter Bakehouse Recalls Donutful Chocolate Dipped Vanilla Cake Donuts for Undeclared Milk
FDA (Food) · 2026-10-14
- HighFreshPoint Recalls Cranberry Chicken Salad Wedges for Undeclared Egg Allergen
FDA (Food) · 2026-10-14
- HighJ K Patisserie & Bakery LLC Recalls Croissants for Undeclared Egg
FDA (Food) · 2026-10-14
- LowMindray ePM Series Patient Monitor Manuals Recalled for Alarm Clarification
FDA (Devices) · 2026-10-14
Similar recalls
- HighZimmer NexGen Knee Implant Components Recalled for Surgical Delay Risk
FDA (Devices) · 2013-12-18
- HighZimmer NexGen Knee Instruments Recalled Due to Surgical Delay Risk
FDA (Devices) · 2013-12-18
- HighZimmer NexGen Knee Instruments Recalled Due to Potential Surgical Delay
FDA (Devices) · 2013-12-18
- ModerateZimmer NexGen Knee Implant Recall Due to Sealer Calibration Issues
FDA (Devices) · 2016-03-23
- ModerateZimmer Recalls NexGen Knee Components Due to Thread Specification Issues
FDA (Devices) · 2014-07-09
- HighZimmer Recalls NexGen Knee Components Due to Manufacturing Cleaning Defects
FDA (Devices) · 2012-12-05