Agency classClass IIOur severity:Moderate FDA (Devices)·Z-0590-2016·Announced 2016-01-13

Zimmer NexGEN Tibial Components Recalled Due to Labeling Error

Zimmer Manufacturing B.V. is recalling specific NexGEN System tibial components because a carton was mislabeled, containing a different component than indicated.

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 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, and the source text describes a labeling error without reporting any injuries, illnesses, or deaths, fitting the criteria for a moderate severity voluntary precautionary recall.

Plain-English summary

Zimmer Manufacturing B.V. is recalling specific lots of NexGEN System tibial components, including REF 5980-37-01 and REF 5986-37-01. The recall was initiated after a product complaint indicated that a carton labeled as a Precoat Stemmed Tibia Size 3 contained a non-augmented Stemmed Tibia Plate size 3 instead.

The affected units were distributed worldwide to Germany, Belgium, Denmark, France, the UK, Greece, Ireland, the Netherlands, Norway, the Russian Federation, Saudi Arabia, Sweden, and Thailand. The recall involves 384 distribution events, with 383 units remaining after one was returned.

Healthcare providers and facilities should check their inventory for these specific reference numbers and lot numbers (62491580 and 62460315). If these components are found, they should be removed from use and returned to the manufacturer or authorized representative.

The recalled product

Product: NexGEN System REF 5980-37-01 Tibial Component Size Stemmed 3 Precoat, and REF 5986-37-01 Nonaugmentable Tibial Component Option CR/PS/LPS Size Stemmed 3. Tibial component of implanted knee prosthesis.
Manufacturer: Zimmer Manufacturing B.V.
Category: Medical Device — Orthopedic Implant
Hazard: mis-labeling

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)

lots 62491580 (P/N 00598003701) and 62460315 (P/N 00598603701)

Distribution

Distribution scope not specified by the agency.

Same manufacturer · Zimmer Manufacturing B.V.

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