Recall Z-1620-2013 ยท LXH Orthopedic Manual Surgical Instrument
Zimmer, Inc.
Bigliani/Flatow The Complete Solution Fukuda Retractors Large Nonsterile 4305-19-40. Used in retracting the humeral shaft posteriorly and exposing the entire glenoid surface.
| Date | Jul 1, 2013 (initiated May 23, 2013) |
| Status | Terminated |
| Reason | This is a recall expansion from the 2010 recall which now includes seven additional lots that were not previously included. Zimmer, Inc. is initiating a recall of small and large Fukuda-type retractors due to fractures occurring at the grooves around the perimeter of the blades while being used during surgery. |
| Root cause | Device Design |
| Action | In 2010, Zimmer initiated a recall of the Bigliani/Flatow Fukuda Retractors due to fractures occurring at the grooves around the perimeter of the blades. Zimmer is expanding this recall to include seven lots that were not previously included. On 5/23/13, an Urgent Medical Device Recall notification letter went to all consignees explaining the recall expansion and risk associated with the recall. All consignees are to locate and quarantine the device immediately. Please return the product along with the completed inventory certification form to Zimmer. If you have any questions regarding th |
| Quantity | 722 units (includes 2010 market withdrawal) |
| Distribution | Worldwide Distribution-USA (nationwide) including the states of NY, MI, MN, OH, IN, IL, VA, MD, PA, WA, KY, CT, RI, NH, TX, MT, and CA and the countries of Chile, China, South Korea, and Australia. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.