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U.S. Department of Health and Human Services

Class 2 Device Recall Synthes Battery Power Line II Oscillator

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  Class 2 Device Recall Synthes Battery Power Line II Oscillator see related information
Date Initiated by Firm July 01, 2015
Date Posted August 05, 2015
Recall Status1 Terminated 3 on December 14, 2016
Recall Number Z-2345-2015
Recall Event ID 71659
Product Classification Instrument, cutting, orthopedic - Product Code HTZ
Product Synthes Battery Power Line II Oscillator Model 530.710, orthopedic surgical power tool.
Code Information Serial numbers: 100067, 100076, 100371, 100372, 100063, 100065, 100069, 100076, and 100055; Foreign: Item number 530.710 Serial numbers: 100020, 100026, 100039, 100248, 100254, 100257, 100263, 100265, 100269, 100270, 100293, 100296, 100307, 100313, 100315, 100339, and 100340.
Recalling Firm/
Manufacturer		 The Anspach Effort, Inc.
4500 Riverside Dr
Palm Beach Gardens FL 33410-4235
For Additional Information Contact Complaint Handling Unit Manager
561-494-3673
Manufacturer Reason
for Recall		 Saw head separated from the drive unit or began to come loose.
FDA Determined
Cause 2		 Nonconforming Material/Component
Action DePuy Synthes sent an " Urgent Notice Medical Device Recall (Removal) letter dated July 1, 2015, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. ACTION REQUIRED: Our records show that your facility has the affected product(s) subject to this removal. The Anspach Effort, on behalf of DePuy Synthes asks that you review your inventory and immediately remove any affected BPLII Battery Oscillator devices from stock. In addition to this letter, your DePuy Synthes Sales Consultant has been provided with new product(s) to immediately replace the affected product(s). If you have any questions regarding this removal, please contact the Complaint Handling Unit Manager at 561-494-3673 or contact your DePuy Synthes Sales Consultant.
Quantity in Commerce 360 handpieces (Currently there are 9 affected units remaining in the US and 17 units OUS all others were reworked)
Distribution Worldwide Distribution - US Distribution to the states of : AR, LA, OH, and WA., and the countries of : China, France, Italy, Russia, South Africa, Switzerland, and United Kingdom.
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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