The Recall Desk
ModerateFDA (Devices)·Z-1046-2016·Announced 2016-03-16

Zimmer Biomet Recalls M/L Taper Hip Prosthesis Due to Etching Error

Zimmer Biomet is recalling a specific lot of M/L Taper Hip Prostheses because the device was incorrectly etched as 'STD' instead of 'EXT', although the packaging is correct.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, but the hazard is a labeling/etching discrepancy where the physical device matches the correct packaging, representing a minor labeling error without reported injuries.

Plain-English summary

Zimmer Biomet, Inc. initiated a voluntary recall on February 11, 2016, for a single manufacturing lot of M/L Taper Hip Prostheses. The affected product is Item 00-7711-012-20, Lot 62937093, specifically Size 12.5, Extended Offset stems. A total of 9 units are involved in this recall.

The recall was initiated because the device was incorrectly etched with the label 'STD' rather than 'EXT'. Despite this error on the device itself, the product packaging is correctly labeled as 'Extended Offset,' and the device is indeed an extended offset stem.

The affected units were distributed in the states of South Dakota, Missouri, New York, Michigan, Pennsylvania, Kentucky, and Tennessee, as well as in the country of Argentina. Consumers and healthcare providers should verify the item and lot numbers of any M/L Taper Hip Prostheses in their possession against the recalled codes and contact Zimmer Biomet for further instructions.

The recalled product

Product
M/L Taper Hip Prosthesis (Item: 00-7711-012-20, Lot: 62937093
Affected units
9

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 (2)

  • Item: 00-7711-012-20
  • Lot: 62937093

Distribution

Distributed in 8 states: