The Recall Desk
HighFDA (Devices)·Z-0460-2014·Announced 2013-12-18

Zimmer NexGen Porous Patella Drill Guide Recall Expansion

Zimmer, Inc. is expanding a recall of NexGen Porous Patella Drill Guides to prevent 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 (surgical instrument) where the hazard is the potential for inadvertent use causing surgical delays, but no injuries or illnesses have been reported.

Plain-English summary

Zimmer, Inc. is expanding a previous recall of NexGen Micro components to include five additional instruments associated with the NexGen Complete Knee Solution Porous Patella Drill Guide. The recall involves 641 units of the 29mm diameter, 10mm thickness drill guide, identified by Part Number 00-5879-067-29. These devices are non-sterile, prescription-only instruments used in total knee arthroplasty.

The recall is being 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 of the NexGen Micro components.

The affected devices were distributed worldwide, including nationwide in the United States and internationally to Australia, Belgium, Canada, Denmark, Ecuador, Germany, India, Italy, Japan, Korea, Malaysia, Mexico, Netherlands, Peru, Singapore, South Africa, Spain, Switzerland, UAE, and the UK. Healthcare providers should stop using these specific instruments and contact Zimmer, Inc. for further instructions.

The recalled product

Product
NexGen Complete Knee Solution Porous Patella Drill Guide-29mm dia./10mm thickness Non sterile, Rx Only 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-traumat
Manufacturer
Zimmer, Inc.
Affected units
641

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 00-5879-067-29

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 →