Z-2227-2014 Class II Terminated
FDA device recall Z-2227-2014 was initiated by Zimmer, Inc. on Jul 23, 2014 and is designated Class II. Reason for recall: The firm received complaints for failure of the handle to remain assembled to the rasp during use due to various failure modes, including fracture of the leaf spring. The recall status is terminated (terminated Sep 15, 2015). Affected quantity: 412 units.
Recall Details
- Product Type
- Devices
- Report Date
- Aug 20, 2014
- Initiation Date
- Jul 23, 2014
- Termination Date
- Sep 15, 2015
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 412 units
Product Description
Double Offset Rasp Handle, Right Hand A/S Rasp Handle (Right)
Reason for Recall
The firm received complaints for failure of the handle to remain assembled to the rasp during use due to various failure modes, including fracture of the leaf spring.
Distribution Pattern
Worldwide Distribution-USA (nationwide) including the states of AK, AL, AZ, CA, CO, FL, GA, IN, KS, KY, MI, MN, NC, NJ, NY, OH, OK, OR, PA, SD, TN, TX, UT, and VA, and the countries of Australia, France, Germany, Italy, Switzerland, and Canada.
Code Information
Item Number 00780803522 Lot Number 56474889, 56474890, 56474895, 56474896
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-2227-2014
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026