Zimmer Recalls Double Offset Rasp Handles Due to Assembly Failure
Zimmer, Inc. is recalling 412 Double Offset Rasp Handles because the handle may fail to remain assembled to the rasp during use.
What this means for you
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: The recall is classified as FDA Class II. The hazard involves a mechanical failure (fracture of the leaf spring) during use of a surgical instrument, which presents a risk of harm to the patient or provider, but the source text does not report specific injuries or illnesses.
Plain-English summary
Zimmer, Inc. is recalling 412 units of the Double Offset Rasp Handle, Right Hand (Item Number 00780803522). The affected lots are 56474889, 56474890, 56474895, and 56474896. These medical devices were distributed nationwide in the United States and in Australia, France, Germany, Italy, Switzerland, and Canada.
The recall was initiated after the firm received 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 the issue.
Healthcare providers and consumers should stop using the affected devices immediately. Users should contact Zimmer, Inc. for instructions on how to return the product or obtain a replacement.
The recalled product
- Product
- Double Offset Rasp Handle, Right Hand A/S Rasp Handle (Right)
- Manufacturer
- Zimmer, Inc.
- 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 (4)
- Item Number 00780803522 Lot Number 56474889
- 56474890
- 56474895
- 56474896
Distribution
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.
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