Zimmer NexGen Knee Instruments Recalled Due to Surgical Delay Risk
Zimmer, Inc. is recalling five NexGen knee instruments to prevent their inadvertent use during surgery, which could cause delays.
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 involves a risk-of-harm product (medical device) where the hazard is a surgical delay and no injuries or illnesses have been reported, fitting the 'High' severity criteria.
Plain-English summary
Zimmer, Inc. is recalling five additional NexGen Micro knee instruments as an expansion of a June 2013 recall. The recalled items are identified by Part Number 00-5971-031-09 and are associated with the NexGen Micro components.
The recall is issued because there is a potential for these specific instruments to be inadvertently utilized during surgery. If used, this would result in a delay because the associated implants are not available due to the previous recall.
The recall affects 684 units that were distributed worldwide, including the United States and various international markets. Healthcare providers should stop using these instruments and contact Zimmer, Inc. for further instructions.
The recalled product
- Product
- NexGen Complete Knee Solution CR Articular Surface Provisional-Yellow 9mm Height Nonsterile Devices are used in total knee arthroplasty and indicated for patients with severe pain and disability due to conditions such as arthritis, collagen disorders, post-traumatic loss of j
- Manufacturer
- Zimmer, Inc.
- Affected units
- 684
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)
- Part Number 00-5971-031-09
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 5 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 5 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 · surgical delay
See all →- HighAnti-Torque Instrument in Vector Pedicle Screw System Recalled
FDA (Devices) · 2026-08-12
- ModeratePhasor neurosurgical drills may have a reverse battery orientation
FDA (Devices) · 2025-08-06
- HighShoulder Prosthesis Stem Excess Material Prevents Proper Surgical Assembly
FDA (Devices) · 2025-03-26
- HighAnatomic lateral fibula plate locking screw failure during surgery
FDA (Devices) · 2025-03-05
- HighOrthopedic fibula plate locking screw failure during surgery
FDA (Devices) · 2025-03-05