The Recall Desk
SevereFDA (Devices)·Z-2231-2014·Announced 2014-08-20

Zimmer Recalls 23.5 Degree Rasp Handle Assemblies Due to Assembly Failure

Zimmer, Inc. is recalling 23.5 Degree Rasp Handle Assemblies because the handle may fail to remain attached to the rasp during use.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall is classified as FDA Class II. Per the rubric, FDA Class II recalls involving significant injury or structural defects are rated as Severe (4).

Plain-English summary

Zimmer, Inc. is recalling 23.5 Degree Rasp Handle Assemblies (Item Number 82-0167-636-20, Lot Numbers 97009531 and 97009781). The recall involves nonsterile, right-sided handles distributed nationwide in the United States and in Australia, France, Germany, Italy, Switzerland, and Canada.

The firm received complaints that the handle failed to remain assembled to the rasp during use. The failure modes included fracture of the leaf spring. This is an FDA Class II recall.

Healthcare providers should stop using the affected devices and contact Zimmer, Inc. for instructions on return or replacement.

The recalled product

Product
23.5 Deg Rasp Handle Assy- RIGHT Nonsterile
Manufacturer
Zimmer, Inc.

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 Number 82-0167-636-20 Lot Number 97009531
  • 97009781

Distribution

Distributed nationwide across the United States.

The notice also names 24 states specifically:

Part of a larger recall action

This product is one of 16 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 16 products in this recall →