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Class 1 Device Recall Adaptor for SBD II |
![see related information](../images/related-info.gif) |
Date Initiated by Firm |
June 24, 2016 |
Date Posted |
September 27, 2016 |
Recall Status1 |
Terminated 3 on June 09, 2018 |
Recall Number |
Z-2784-2016 |
Recall Event ID |
74835 |
510(K)Number |
K043310
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Product Classification |
Instrument, surgical, orthopedic, ac-powered motor and accessory/attachment - Product Code HWE
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Product |
Adaptor for Small Battery Drive and Small Battery Drive II.
Product Usage: The Light Adaptor for Small Battery Drive (SBD) /Small Battery Drive II (SBD II) is designed for use in traumatology and orthopedic surgery of the skeleton, i.e. drilling, reaming or cutting bone. The Adaptors (05.001.024 and 05.001.108) can be used with one of the electrical consoles belonging to the Electric Pen Drive (EPD) to operate the Small Battery Drive and Small Battery Drive II.
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Code Information |
Model/Catalog: Adapter for Small Battery Drive and Small Battery Drive II for Electric Pen Drive 05.001.024; Lot/Set/Serial: All Manufactured Lots/Serial Numbers. |
Recalling Firm/ Manufacturer |
The Anspach Effort, Inc. 4500 Riverside Dr Palm Beach Gardens FL 33410-4235
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For Additional Information Contact |
Jody Cadd 610-314-2106
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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.
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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
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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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510(K) Database |
510(K)s with Product Code = HWE and Original Applicant = SYNTHES (USA)
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