Agency classClass IIOur severity:High FDA (Devices)·Z-0459-2014·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 include five additional instruments. These devices may be inadvertently used during surgery, causing 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 risk-of-harm product (medical device) where the hazard is the potential for inadvertent use during surgery resulting in delay, 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. The specific product involved is the NexGen Complete Knee Solution Porous Patella Drill Guide (26mm dia./10mm thickness), part number 00-5879-067-26. A total of 625 units were distributed worldwide, including in the United States and various international markets.

The recall is being issued because these instruments are associated with the NexGen Micro components. There is a potential for these devices to be inadvertently utilized during surgery, which would result in a delay. The associated implants are not available due to the previous recall.

Healthcare providers and facilities should stop using these specific instruments immediately. Zimmer, Inc. is the recalling firm responsible for managing this recall.

The recalled product

Product: NexGen Complete Knee Solution Porous Patella Drill Guide-26mm 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…
Manufacturer: Zimmer, Inc.
Category: Medical Device — Surgical Instrument
Hazard: surgical-delay
inadvertent-use
Affected units: 625

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 00-5879-067-26

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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