The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-2519-2023·Announced 2023-09-13

Hip Prosthesis Implants Recalled for Size Mismatch Between Label and Device

Zimmer, Inc. is recalling M/L Taper Hip Prosthesis implants where the outer package labeling and product etch do not match the actual implant size. This mislabeling could lead to implantation of the wrong-sized prosthesis.

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: This is an FDA Class II recall involving labeling and product marking errors that could result in implantation of wrong-sized hip prostheses. No illnesses, injuries, or hospitalizations have been reported, limiting the severity to the risk-of-harm category.

Plain-English summary

Zimmer, Inc. is recalling M/L Taper Hip Prosthesis Extended Offset, Reduced Neck Length implants in Size 4 (Item Number 00771100640) and Size 6 (Item Number 00771100440). The issue involves a labeling and product marking error: the outer package and product etch may indicate one size while the implant itself is the opposite size.

Specifically, some units labeled as Size 6 contain Size 4 implants, while other units labeled as Size 4 contain Size 6 implants. This mismatch between the label and the actual device could result in implantation of an incorrect-sized prosthesis, potentially leading to surgical complications or the need for revision procedures.

The recall affects 24 units distributed worldwide, including the United States (Alabama, California, Georgia, Michigan, New Jersey, Pennsylvania, Tennessee, and Wisconsin), Brazil, Canada, and the Netherlands.

Patients or physicians who have received or implanted these prostheses should contact Zimmer, Inc. for guidance. Healthcare facilities should quarantine affected inventory pending instructions from the manufacturer.

The recalled product

Product
M/L Taper Hip Prosthesis Extended Offset, Reduced Neck Length, Size 4 (Item Number 00771100640) and Size 6 (Item Number 00771100440)
Manufacturer
Zimmer, Inc.
Category
Medical Device — Hip Prosthesis
Hazard
Affected units
24

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 (6)

  • Item Number: 00771100640
  • UDI-DI: 00889024131699
  • Lot Number: 65236202
  • Item Number: 00771100440
  • UDI-DI: 00889024131613
  • Lot Number: 65249215

Distribution

Distributed nationwide across the United States.

The notice also names 8 states specifically:

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