The Recall Desk
HighFDA (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.

What this means for you

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 fo
Manufacturer
Zimmer, Inc.
Category
Medical Device — Orthopedic Implant
Hazard
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 →

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