The Recall Desk
HighFDA (Devices)·Z-2033-2014·Announced 2014-07-16

Zimmer M/L Taper Hip Stem Recall Due to Black Residue

Zimmer, Inc. is recalling M/L Taper Hip Stems because black residue was observed in the sterile pouches. The recall covers 1,487 units distributed worldwide.

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, and the presence of black residue in a sterile implant pouch represents a risk of harm to patients, although no specific injuries or illnesses are reported in the source text.

Plain-English summary

Zimmer, Inc. is recalling the M/L Taper Hip Stem Standard & Extended Offset, a femoral stem component of a modular hip joint prosthesis system. The recall is being conducted because black residue was observed in the sterile pouches of the affected devices.

The recall involves 1,487 units of the hip stem, available in various sizes including 5.0, 7.5, 9.0, 10.0, 11.0, 12.5, 13.5, 15.0, 11.25, 17.25, 20.0, and 22.5. The affected products were distributed worldwide, including in the United States, Australia, Canada, China, Europe, India, Japan, Korea, and Singapore.

Patients who have had these hip stems implanted should contact their healthcare provider for further evaluation and guidance. The FDA has classified this recall as Class II, indicating that use of the product could cause temporary or medically reversible adverse health consequences.

The recalled product

Product
Zimmer M/L Taper Hip Stem Standard & Extended Offset, HIP JOINT PROSTHESIS, Sizes: 5.0, 7.5, 9.0, 10.0, 11.0, 12.5, 13.5, 15.0, 11.25, 17.25, 20.0 & 22.5. The femoral stem component of a modular system that consists of an acetabular component, femoral head, femoral stem, and
Manufacturer
Zimmer, Inc.
Category
Medical Device — Orthopedic Implant
Hazard
Affected units
1,487

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: 00771100500
  • Lot #: 60418073
  • 60814878
  • 61085493
  • 61221743
  • 61576204
  • 61621459
  • 61621460
  • 61801966
  • 61825644
  • 61825646
  • 61851938
  • 61856660
  • 61899990
  • 61909935
  • 61957246
  • 61963045
  • 61967714
  • 61978787
  • 62004470

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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