Recall Z-1953-2013 ยท LXH Orthopedic Manual Surgical Instrument
Zimmer, Inc.
REF 00-4309-071-36 Trabecular Metal Reverse Shoulder System Instrumentation, Glenosphere Helmet, 36 mm Diameter Nonsterile, Qty -1 Instrumentation used in shoulder replacement surgery. The glenosphere helmet is used to insert the glenosphere onto the base plate prior to impaction with the glenospere impactor.
| Date | Aug 12, 2013 (initiated Jun 28, 2013) |
| Status | Terminated |
| Reason | There is potential for one or both tabsof theTrabecular Metal Reverse Glenosphere Helmet to fracture during use and become disassociated from the device. There have been 47 reported complaints of tab fracture. |
| Root cause | Device Design |
| Action | Zimmer Inc sent Urgent Medical Device Recall notifications on June 28, 2013, to all affected customers. The initial letter identified the issue, possible adverse consequences and informed customers that a replacement would be available in the coming months. In addition, the letter included references to both the TM Reverse Surgical Technique and to the video available on Zimmer TV and Zimmer.com. Both resources explain in detail the proper technique for utilization of the Glenosphere Helmet. Proper utilization of the Glenosphere Helmet dramatically reduces the likelihood of fracture. Distr |
| Quantity | 3,163 |
| Distribution | Worldwide Distribution - USA (nationwide) and internationally to Australia, Austria, Belgium, Brazil, Canada, China, Czech Republic, Denmark, Finland, France, Germany, Greece, India, Israel, Italy, Korea, Lebanon, Malta, Netherlands, Norway, Portugal, Singapore, Spain, Sweden, Switzerland, Taiwan, T |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.