The Recall Desk
ModerateFDA (Devices)·Z-0183-2013·Announced 2012-11-07

Wright Medical Recalls Hip Components Due to Potential Shelf Life Labeling Errors

Wright Medical Technology Inc. is recalling 31,566 hip implant components distributed worldwide due to potential inaccuracies in labeled shelf life.

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 specific hazard is a labeling error regarding shelf life. Per the rubric, minor labeling errors and voluntary precautionary recalls without reported injuries or illnesses fall under the Moderate (2) category.

Plain-English summary

Wright Medical Technology Inc. is recalling 31,566 units of various hip implant components, including Profemur Z femoral stems, Procotyl E revision shells, and Collegia mobile inserts. The recall is initiated because there may be inaccuracies on the labeled shelf life for all products packaged at the Toulon, France facility.

The affected products were distributed nationwide in the United States and internationally to numerous countries, including Canada, the United Kingdom, Germany, France, Japan, and Australia. The recall covers a wide range of specific lot numbers and product codes associated with the Toulon facility packaging.

Consumers and healthcare providers should check their inventory for the specific lot numbers and product codes listed in the official recall notice. If the products are found, they should be removed from use and returned to the manufacturer or an authorized distributor for credit or replacement, as directed by Wright Medical Technology Inc.

The recalled product

Product
Hip Components: INSERT MOBILE "COLLEGIA" TAILLE 58*28, OT22C58, Lot Numbers: W07335080 and X06391225 INSERT MOBILE "COLLEGIA" TAILLE 60*28, OT22C60, Lot Number: X06391226 TETE INOX "COLLEGIA" T 28/0 CONE 6 DEG. -N30NW-, OT32H28, Lot Numbers: 068573172 and X03396534 PROFEMU
Affected units
31,566

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)

  • INSERT MOBILE "COLLEGIA" TAILLE 58*28
  • OT22C58
  • Lot Numbers: W07335080 and X06391225 INSERT MOBILE "COLLEGIA" TAILLE 60*28
  • OT22C60
  • Lot Number: X06391226 TETE INOX "COLLEGIA" T 28/0 CONE 6 DEG. -N30NW-
  • OT32H28
  • PHA00232
  • Lot Number: X05420041 PROFEMUR(R) Z FEMORAL STEM S 5 CEMENT LESS
  • PHA00240
  • Lot Number: V03156757 PROFEMUR(R) Z FEMORAL STEM S 8 CEMENT LESS
  • PHA00246
  • Lot Number: X05410982 PROFEMUR(R) Z FEMORAL STEM S 9 CEMENT LESS
  • PHA00248
  • Lot Numbers: V01132375
  • W03314591
  • X01383213
  • X02388533
  • X03396459
  • X04401274
  • and X07428776 REVISION SHELL "PROCOTYL(R) E" SIZE 52/60 G1 T/P COATED

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 3 recalled by Wright Medical Technology 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 →