The Recall Desk
SevereFDA (Devices)·Z-2230-2014·Announced 2014-08-20

Zimmer Recalls 23.5 Degree Rasp Handle Assemblies Due to Assembly Failure

Zimmer, Inc. is recalling 412 units of 23.5 Degree Rasp Handle Assemblies because the handle may fail to remain assembled 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 and involves a structural failure of a medical device during use, which aligns with the rubric criteria for a Severe rating.

Plain-English summary

Zimmer, Inc. is recalling 412 units of the 23.5 Deg Rasp Handle Assy- LEFT Nonsterile. The recall involves Item Number 82-0167-636-00, specifically Lot Numbers 97009530 and 97009782. The product was distributed nationwide in the United States and internationally to Australia, France, Germany, Italy, Switzerland, and Canada.

The firm initiated the recall after receiving complaints that the handle failed to remain assembled to the rasp during use. The source text identifies various failure modes, including the fracture of the leaf spring, as the cause of these issues.

This recall is classified as Class II by the FDA. Consumers and healthcare providers should stop using the affected units and contact Zimmer, Inc. for instructions on how to return or replace the product.

The recalled product

Product
23.5 Deg Rasp Handle Assy- LEFT Nonsterile
Manufacturer
Zimmer, Inc.
Category
Medical Device — Surgical Instrument
Hazard
Affected units
412

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 82-0167-636-00 Lot Number 97009530
  • 97009782

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 →

Related recalls

Same manufacturer · Zimmer, Inc.

See all →

Same hazard · structural failure

See all →