Agency classClass IIOur severity:High FDA (Devices)·Z-1148-2016·Announced 2016-03-23

Zimmer NexGen MIS Tibia Plate Recall for Sterility Concerns

Zimmer Manufacturing B.V. is recalling NexGen MIS Tibia Plates due to insufficient sealer calibration data, raising concerns about the sterility of the devices.

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 (sterile medical device) where the hazard is theoretical (potential loss of sterility) and no injuries or illnesses have been reported in the source text.

Plain-English summary

Zimmer Manufacturing B.V. is recalling NexGen MIS Tibia Plates used in total knee arthroplasty. The recall involves 5,567 units distributed nationwide in the United States. The specific product codes and item numbers are listed in the official recall documentation.

The reason for the recall is insufficient sealer calibration data for products packaged in the firm's Building II between August 2010 and April 2013. This issue affects the sterility of the devices, which are intended to be sterile for surgical use.

Healthcare providers and patients should check their inventory and patient records for the affected lot numbers. If a patient has received one of these devices, they should consult with their healthcare provider regarding the potential risks associated with the sterility concern.

The recalled product

Product: Product 50 consists of all product under product code: JWH and same usage: Item no: 595002701 NEXGEN MIS TIBIA PLATE PR 595002702 NEXGEN MIS TIBIA PLATE PR 595003701 NEXGEN MIS TIBIA PLATE PR 595003702 NEXGEN MIS TIBIA PLATE PR 595003712 NEXGEN MIS TIBIA PLATE PR…
Manufacturer: Zimmer Manufacturing B.V.
Category: Medical Device — Orthopedic Implants
Hazard: sterility
infection
Affected units: 5,567

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 72 recalled by Zimmer Manufacturing B.V. 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 72 products in this recall →

Same manufacturer · Zimmer Manufacturing B.V.

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Same hazard · sterility