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U.S. Department of Health and Human Services

Class 2 Device Recall Synthes Small Battery Drive (SBD) Oscillating Saw Attachment Part Number: 532.021

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 Class 2 Device Recall Synthes Small Battery Drive (SBD) Oscillating Saw Attachment Part Number: 532.021see related information
Date Initiated by FirmMarch 24, 2015
Date PostedApril 30, 2015
Recall Status1 Terminated 3 on December 14, 2016
Recall NumberZ-1553-2015
Recall Event ID 70919
Product Classification Instrument, surgical, orthopedic, ac-powered motor and accessory/attachment - Product Code HWE
ProductSynthes Small Battery Drive (SBD) Oscillating Saw Attachment Part Number: 532.021 for orthopedic surgery.
Code Information ALL Lots
Recalling Firm/
Manufacturer		 The Anspach Effort, Inc.
4500 Riverside Dr
Palm Beach Gardens FL 33410-4235
For Additional Information ContactJennifer Breston
561-627-1080
Manufacturer Reason
for Recall		The potential exists for the Oscillating Saw Attachment to disengage from the Small Battery Drive handpiece. If the attachment disengages from the handpiece intra-operatively, there is a potential for injury to the patient and/or user.
FDA Determined
Cause 2		Device Design
ActionDePuySynthes sent a "URGENT NOTICE: MEDICAL DEVICE RECALL- CORRECTION" letter dated March 24, 2015 to all affected customers. The letter describes the product, problem, and the actions to be taken by the customers. The firm requests that customers review the inventory and perform the in-process inspection outlined in the letter attachment, a review and repair will be implemented if necessary during the next visit schedule maintenance interval at the customer site. Customers having questions regarding this notice should contact the firm Complaint Handling Unit Manager at 561-494-3673 or to contact their Depuy Synthes Sales Consultant. For questions regarding this recall call 561-627-1080.
Quantity in Commerce12,085 pieces
DistributionWorldwide Distribution - US (nationwide including DC, Hawaii, and Puerto Rico) and Internationally to Argentina, Austria, Australia, Belgium, Bahrain, Bolivia, Brazil, Canada, China, Chile, Costa Rica, Czech Republic, Germany, Denmark, Ecuador, Egypt, Spain, Finland, France, Great Britain, Greece, Guatemala, Hong Kong, Croatia, Hungary, Indonesia, Ireland, Israel, India, Iraq, Iran, Italy, Jordan, Japan, Kenya, Korea, Kuwait, Lebanon, Sri Lanka, Libyan Arab Jamahiriya, Morocco, Macedonia, Mexico, Malaysia, Netherlands, Norway, Nepal, New Zealand, Oman, Ontario, Peru, Philippines, Palestine, Portugal, Romania, Serbia, Russian Federation, Saudi Arabia, Sweden, Singapore, Slovenia, Slovakia, South Africa, El Salvador, Thailand, Turkey, Taiwan, Ukraine, Uruguay, Venezuela, Vietnam and United Arab Emirates.
Total Product Life CycleTPLC 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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