Agency classClass IIOur severity:High FDA (Devices)·Z-2035-2014·Announced 2014-07-16

Zimmer M/L Taper Hip Prosthesis Recalled Due to Black Residue

Zimmer, Inc. is recalling M/L Taper Hip Prostheses with Kinectiv Technology 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 is classified as FDA Class II. The hazard involves potential contamination (black residue) in a sterile medical device, which poses a risk of harm, but no specific injuries or illnesses are reported in the source text.

Plain-English summary

Zimmer, Inc. is recalling 315 units of the M/L Taper Hip Prosthesis with Kinectiv Technology. The recall involves femoral stem components in sizes 4, 5, 6, 7.5, 9, 10, 11, and 12.5. The product is a modular system component used for hip joint replacement.

The recall was initiated because black residue was observed in the sterile pouches of the affected stems. The FDA has classified this as a Class II recall. The affected units were distributed worldwide, including the United States, Australia, Canada, China, Europe, India, Japan, Korea, and Singapore.

Healthcare providers and patients should contact Zimmer, Inc. for instructions on how to handle the affected devices. Specific lot numbers and product IDs are listed in the official recall documentation.

The recalled product

Product: Zimmer M/L Taper Hip Prosthesis with Kinectiv Technology, 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-compromise
Affected units: 315

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: 00771300500
Lot #: 61694618
61743290
61812682
61845568
61845569
61972395
61972396
61978915
62030113
62044919
62118875
62134957
62163650
62169474
62225879
62225880
62354721
62418036
62418040

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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