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U.S. Department of Health and Human Services

Class 2 Device Recall Spinal Rod Cutter

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  Class 2 Device Recall Spinal Rod Cutter see related information
Date Initiated by Firm November 20, 2020
Create Date December 22, 2020
Recall Status1 Terminated 3 on May 26, 2022
Recall Number Z-0696-2021
Recall Event ID 86869
Product Classification Cutter, wire - Product Code HXZ
Product Spinal Rod Cutter, Item number 00392500200. The product is a nonsterile pin cutter - Product Usage: The intended use of this instrument is to be used for cutting orthopedic rods/pins during orthopedic surgeries.
Code Information All lots
Recalling Firm/
Manufacturer		 Zimmer Biomet, Inc.
1800 W Center St
Warsaw IN 46580-2304
For Additional Information Contact 411 Technical Services
574-371-3071
Manufacturer Reason
for Recall		 Device has the potential for fracture during use.
FDA Determined
Cause 2		 Under Investigation by firm
Action The firm distributed Urgent Medical Device Recall and Notice of Discontinuation letters to affected customers on November 20, 2020. Customers were informed of the product's potential for fracture during use. Customers were asked to locate and quarantine affected product and to return all affected product to the firm. The firm is discontinuing this product; it will not longer be available. If you have questions regarding this recall, please contact the firm's customer service at 574-371-3071 between 8:00 am and 5:00pm EST, Monday through Friday. Calls received outside of call center operating hours will receive a voicemail prompt or be transferred to an on-call representative in the event of an emergency. Alternatively, your questions may be emailed to CorporateQuality.PostMarket@zimmerbiomet.com.
Quantity in Commerce 4713
Distribution Domestic distribution nationwide. Foreign distribution to Australia, China, Hong Kong, India, Japan, Korea, New Zealand, Taiwan, Singapore, Thailand, Canada, Netherlands, Argentina, Brazil, Mexico, Venezuela, Panama, and Chile.
Total Product Life Cycle TPLC Device Report
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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