Agency classClass IIOur severity:High FDA (Devices)·Z-0463-2014·Announced 2013-12-18

Zimmer NexGen Knee Instruments Recalled Due to Potential Surgical Delay

Zimmer, Inc. is recalling five NexGen Micro knee instruments because they may be used incorrectly, causing surgical delays.

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 involves a medical device where the hazard is a risk of harm (surgical delay) without reported injuries, fitting the High severity criteria.

Plain-English summary

Zimmer, Inc. is recalling five additional NexGen Micro knee instruments. This action expands a previous recall from June 2013. The recalled items are part of the NexGen Complete Knee Solution system used in total knee arthroplasty.

The recall is necessary because these specific instruments are associated with NexGen Micro components that were previously recalled. There is a potential for these instruments to be inadvertently utilized during surgery, which could result in a delay. The associated implants are not available due to the previous recall.

The recall affects 439 units distributed worldwide, including the United States and various international markets. Healthcare providers should stop using these instruments and contact Zimmer, Inc. for instructions on return or replacement.

The recalled product

Product: NexGen Complete Knee Solution CR Articular Surface Provisional-Striped Green 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…
Manufacturer: Zimmer, Inc.
Category: Medical Device — Orthopedic Surgical Instrument
Hazard: surgical-delay
inadvertent-use
Affected units: 439

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 00-5971-041-09

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 →

Same manufacturer · Zimmer, Inc.

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