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U.S. Department of Health and Human Services

Class 1 Device Recall Light Adaptor for SBD & SBD II

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  Class 1 Device Recall Light Adaptor for SBD & SBD II see related information
Date Initiated by Firm June 24, 2016
Date Posted September 27, 2016
Recall Status1 Terminated 3 on June 09, 2018
Recall Number Z-2783-2016
Recall Event ID 74835
510(K)Number K043310  
Product Classification Instrument, surgical, orthopedic, ac-powered motor and accessory/attachment - Product Code HWE
Product Light Adaptor for Small Battery Drive and Small Battery Drive II.

Code Information Model/Catalog: Part # (05.001.108 and 05.001.024) Serial: All Serial Numbers.
Recalling Firm/
Manufacturer		 The Anspach Effort, Inc.
4500 Riverside Dr
Palm Beach Gardens FL 33410-4235
For Additional Information Contact Jody Cadd
610-314-2106
Manufacturer Reason
for Recall		 There was a potential for the Adaptor and Light Adaptor for Small Battery Drive and Small Battery Drive II to generate excessive internal pressure that may cause the products to burst.
FDA Determined
Cause 2		 Device Design
Action An Urgent Notice for this Recall was provided to the consignees on 6/24/2016. They were to review their inventory and return the products with instructions. IF YOU HAVE ANY PRODUCT: To immediately quarantine product so it's not used; ensure all in their facility read the Urgent Notice for the Recall; Call the DePuy Synthes Customer Support to obtain a Return Materials Authorization (RMA) Number; to complete the Verification Section indicating the product subject to recall was located; to return the Verification Section with the product to Product Returns, The Anspach Effort Inc., 4500 Riverside Drive, Palm Beach Gardens, FL 33410; Send a copy of the completed Verification Section to DePuy Synthes, Customer Quality Dept by: FAX (561) 627-2682 or Scan/email: DPYUS-PowerToolsFieldActions@its.jnj.com; Keep the notice visibly posted for awareness until all products have been returned; maintain a copy of the notice subject to this action and keep a copy for your records. The return documentation acknowledges your receipt of the medical device removal information. IF YOU DO NOT HAVE the identified product: complete the Verification Section of the recall, by checking the box indicating no affected product located; Include your name title, address, telephone #, signature and date; Send a copy of the completed Verification Section to DePuy Synthes Customer Quality Dept by: Fax: (561) 627-2682, or Scan/e-mail: DPYUS-PowerToolsFieldActions@its.jnj.com; This return document acknowledges your receipt of medical device removal information; ADVISORY: For Alternative products: This product does not have any inventory for replacement. Since the recall of this device may have an impact on your surgical schedule, DePuy Synthes Power Tools would like to propose alternative products to assist you with a replacement for the Recalled Adaptor (05.100.024) or Light Adaptor (05.001.108) . The products are the Small Battery Drive II Hand-piece (532.110) can also be operated
Quantity in Commerce 1,833 devices (05.001.024 and 05.001.108)
Distribution Worldwide Distribution - US Nationwide and including the countries of Canada, Austria, Australia, Belgium, Brazil, Chile, China, Colombia, Costa Rica, Czech Republic, Denmark, Finland, France, Germany, Hong Kong, Hungary, India, Indonesia, Ireland, Israel, Italy, Japan, Jordan, Kuwait, Libya, Malaysia, Mexico, Nepal, Netherlands, New Zealand, Norway, Poland, Portugal, Romania, Russia, Saudi Arabia, Singapore, Slovenia, Slovakia, Spain, South Africa, South Korea, Sri Lanka, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, and Vietnam, and areas of Middle East, Africa, Asia & Pacific.
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.
510(K) Database 510(K)s with Product Code = HWE and Original Applicant = SYNTHES (USA)
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