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U.S. Department of Health and Human Services

Class 2 Device Recall Synthes Oscillating Saw Attachment/Large w/Key for Small Battery Drive

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  Class 2 Device Recall Synthes Oscillating Saw Attachment/Large w/Key for Small Battery Drive see related information
Date Initiated by Firm October 17, 2011
Date Posted December 02, 2011
Recall Status1 Terminated 3 on December 18, 2014
Recall Number Z-0348-2012
Recall Event ID 60237
Product Classification Instrument, surgical, orthopedic, ac-powered motor and accessory/attachment - Product Code HWE
Product Synthes Oscillating Saw Attachment/Large w/Key for Small Battery Drive.

This surgical instrument motor and accessories are AC-powered, battery-powered or air-powered devices intended for use during surgical procedures to provide power to operate various accessories or attachments to cut hard tissue or bone and soft tissue. Accessories or attachments may include a bur, chisel (osteotome), dermabrasion brush, dermatome, drill bit, hammerhead, pin driver and saw blade.
Code Information Catalog number: 532.026 - All lots
Recalling Firm/
Manufacturer		 Synthes USA (HQ), Inc.
1302 Wrights Ln E
West Chester PA 19380-3417
For Additional Information Contact Customer Support
610-719-5000
Manufacturer Reason
for Recall		 The potential exists for the Large Oscillating Saw Attachment to disengage from the Small Battery Drive handpiece. If the attachment disengages from the handpiece, there is a potential for injury to the patient and/or user.
FDA Determined
Cause 2		 Device Design
Action Synthes sent a "NOTICE: MEDICAL DEVICE RECALL" letter dated October 17, 2011 to all affected customers. The letter describes the product, problem, and the actions to be taken by the customers. The firm requests that customers return their affected device(s) for servicing. Instructions are provided for customers to follow. Customers having questions regarding this notice should contact the firm at 610-719-5450.
Quantity in Commerce 5
Distribution Nationwide Distribution including the states of CO, LA, NY, and OK.
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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