Agency classClass IIOur severity:High FDA (Devices)·Z-2374-2018·Announced 2018-07-11

Zimmer Biomet Recalls M/L Taper Hip Prostheses Due to Black Residue

Zimmer Biomet is recalling 58 M/L Taper Hip Prostheses distributed to Japan due to black residue in the packaging. The residue is biocompatible but may cause surgical delays or wear-related intervention.

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 high-risk medical device where injury has not yet been reported, but there is a risk of harm (surgical intervention/delay) due to debris, fitting the 'High' severity criteria.

Plain-English summary

Zimmer Biomet, Inc. is recalling 58 units of the M/L Taper Hip Prosthesis With Kinective Technology Cementless, Size 7.5 (Catalog Number 00-7713-007-00). These specific devices were manufactured prior to October 2015 and were distributed solely to Japan.

The recall is due to the potential for black residue to be observed within the polyethylene bag containing the implant. The recalling firm states that this residue is a combination of the titanium plasma spray used to create the porous surface of the implant and the polyethylene bag itself. The firm asserts that the residue is biocompatible.

The identified risks include the delay of surgery while locating a replacement device and the potential for surgical intervention due to wear caused by debris. No specific illnesses or injuries are reported in the source text.

The recalled product

Product: Zimmer¿ M/L Taper Hip Prosthesis With Kinective¿ Technology Cementless, Size 7.5; 00-7713-007-00
Manufacturer: Zimmer Biomet, Inc.
Category: Medical Device — Orthopedic Implant
Hazard: debris
surgical-delay
wear
Affected units: 58

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)

62420821 62745221 62848683 63089985 63161324 62647157R

Distribution

Distribution scope not specified by the agency.

Part of a larger recall action

This product is one of 15 recalled by Zimmer Biomet, 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 15 products in this recall →

Same manufacturer · Zimmer Biomet, Inc.

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Same hazard · debris