Recall Z-2784-2016 ยท HWE Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment
The Anspach Effort, Inc.
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 (E
| Date | Sep 27, 2016 (initiated Jun 24, 2016) |
| Status | Terminated |
| Reason | 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. |
| Root cause | 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 Rive |
| Quantity | 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, Malay |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K043310 | SYNTHES (USA) ELECTRIC PEN DRIVE SYSTEM Synthes (Usa), Jan 5, 2005 |