| Class 2 Device Recall 23.5 Degree Anterior Supine Double Offset Rasp Handle | |
Date Initiated by Firm | July 23, 2014 |
Date Posted | August 14, 2014 |
Recall Status1 |
Terminated 3 on September 15, 2015 |
Recall Number | Z-2231-2014 |
Recall Event ID |
68656 |
Product Classification |
Orthopedic manual surgical instrument - Product Code LXH
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Product | 23.5 Deg Rasp Handle Assy- RIGHT
Nonsterile |
Code Information |
Item Number 82-0167-636-20 Lot Number 97009531, 97009781 |
Recalling Firm/ Manufacturer |
Zimmer, Inc. 1800 W Center St Warsaw IN 46580-2304
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For Additional Information Contact | Consumer Relations Call Center 800-447-5633 |
Manufacturer 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. |
FDA Determined Cause 2 | Device Design |
Action | On July 23, 2014, Zimmer issued recall notification to their consignees. Distributors were notified via electronic mail and courier. Recall notification included a description of the issue, affected product, possible risks to patient, and instructions for responding to the recall.
Questions or concerns regarding the recall are directed to Zimmer customer call center @ 1-800-348-2759 M-F, 8am-8pm ET. |
Distribution | 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. |
Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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