Agency classClass IIOur severity:High FDA (Devices)·Z-2034-2014·Announced 2014-07-16

Zimmer Hip Joint Prosthesis Recalled for Black Residue in Sterile Pouches

Zimmer, Inc. is recalling 852 units of M/L Taper Reduced Neck hip joint prostheses because black residue was observed in the sterile pouches.

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 (implanted medical device) where the presence of residue in sterile packaging implies a potential breach of sterility, but the source text does not report any specific injuries or illnesses.

Plain-English summary

Zimmer, Inc. is recalling 852 units of the M/L Taper Reduced Neck Standard & Extended Offset Hip Joint Prosthesis. The recall covers specific sizes (4, 5, 6, 7.5, 9, 10, 11, and 12.5) and multiple lot numbers associated with various product IDs. The product is the femoral stem component of a modular hip replacement system.

The recall was initiated because black residue was observed in the sterile pouches containing the M/L Taper and Kinectiv stems. This observation raises concerns regarding the sterility and integrity of the packaging for these medical devices.

The affected units were distributed worldwide, including the United States, Australia, Canada, China, Europe, India, Japan, Korea, and Singapore. Patients who have had these specific hip joint prostheses implanted should contact their healthcare provider for guidance on whether further evaluation or action is necessary.

The recalled product

Product: Zimmer M/L Taper Reduced Neck Standard & Extended Offset, HIP JOINT PROSTHESIS, Sizes:4, 5, 6, 7.5, 9, 10, 11 & 12.5. The femoral stem component of a modular system that consists of an acetabular component, femoral head, femoral stem, and the instrumentation necessary…
Manufacturer: Zimmer, Inc.
Category: Medical Device — Orthopedic Implant
Hazard: contamination
sterility-breach
Affected units: 852

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 (20)

Product ID: 00771100410
Lot #: 60876583
61098988
61158127
61230791
61542496
61548105
61702995
61729254
61904645
61957233
61963047
61998392
62004467
62067479
62078278
62096889
62107667
62145541
62153634

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 3 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 3 products in this recall →

Same manufacturer · Zimmer, Inc.

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