Agency classClass IIOur severity:High FDA (Devices)·Z-2177-2018·Announced 2018-06-20

Zimmer Biomet Recalls 75mm Tibial Tray Implants Due to Sizing Error

Zimmer Biomet is recalling 16 units of 75mm tibial tray implants that may be incorrectly labeled as 79mm. This error could lead to surgical delays or the need for immediate revision surgery.

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 injury has not yet been reported, but the hazard could lead to immediate revision surgery or surgical delays.

Plain-English summary

Zimmer Biomet, Inc. is recalling 16 units of Biomet Modular Primary Tibial Tray Implants, specifically the Modular Interlok Primary Tray in size 75 mm (Item No. 141215). The recall involves Lot 385340, with UDI (01) 00880304005310 (17) 280306 (10) 385340. These products are used in Total Knee Arthroplasty procedures.

The recall was initiated because one lot of 75mm tibial trays is potentially etched and labeled as a 79 mm tibial tray. This labeling discrepancy may lead to a delay in surgery or require immediate revision surgery to remove an incorrectly sized tibial component after it has been cemented in place.

The affected products were distributed in the United States to the states of Florida, Georgia, Indiana, Massachusetts, New Mexico, Utah, and Wisconsin. Foreign distribution included Canada and Mexico. Healthcare providers and patients should verify the size of the tibial tray implants against the packaging and UDI information to ensure the correct component is used during surgery.

The recalled product

Product: Biomet Modular Primary Tibial Tray Implants; Modular Interlok Primary Tray (size 75 mm); Item No. 141215; UDI: (01) 00880304005310 (17) 280306 (10) 385340 Product is used in Total Knee Arthroplasty
Manufacturer: Zimmer Biomet, Inc.
Category: Medical Device — Orthopedic Implants
Hazard: mis-labeling
surgical-complication
Affected units: 16

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)

Lot 385340 UDI: (01) 00880304005310 (17) 280306 (10) 385340

Distribution

Distributed in 7 states:

Same manufacturer · Zimmer Biomet, Inc.

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Same hazard · mis labeling