Agency classClass IIOur severity:High FDA (Devices)·Z-0461-2014·Announced 2013-12-18

Zimmer NexGen Knee Implant Components Recalled for Surgical Delay Risk

Zimmer, Inc. is recalling 638 NexGen Complete Knee Solution provisional articular surface devices. The recall is an expansion of a previous action to prevent inadvertent use of associated instruments.

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 risk-of-harm product (medical device) where the hazard is the potential for inadvertent use resulting in surgical delay, but no injuries or illnesses have been reported in the source text.

Plain-English summary

Zimmer, Inc. is recalling 638 units of the NexGen Complete Knee Solution CR Articular Surface Provisional-Purple 9mm Height Nonsterile devices. These medical devices are used in total knee arthroplasty for patients with severe pain and disability due to conditions such as arthritis. The devices were distributed nationwide in the United States and internationally to multiple countries including Australia, Canada, Germany, and the UK.

This recall is an expansion of a June 2013 recall of NexGen Micro components. Five additional instruments have been identified that are associated only with the NexGen Micro components. There is a potential for these devices to be inadvertently utilized during surgery, which could result in a delay. The associated implants would not be available due to the previous recall.

Healthcare providers should stop using these devices and contact Zimmer, Inc. for further instructions. Consumers who have had these devices implanted should contact their healthcare provider for guidance.

The recalled product

Product: NexGen Complete Knee Solution CR Articular Surface Provisional-Purple 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…
Manufacturer: Zimmer, Inc.
Category: Medical Device — Orthopedic Implant
Hazard: surgical-delay
inadvertent-use
Affected units: 638

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 00-5971-020-09

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 →

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