Recall Z-0609-2014 ยท KWT Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented
Zimmer, Inc.
Trabecular Metal (TM) Reverse Glenosphere 36mm Part 00-4349-036-11 The reverse shoulder system is used in the treatment of the following: severe pain or significant disability in degenerative, rheumatoid, or traumatic disease of the glenohumeral joint; un-united humeral head fractures of long duration; irreducible 3 and 4-part proximal humeral fractures; avascular necrosis of the humeral head, o
| Date | Dec 30, 2013 (initiated Dec 10, 2013) |
| Status | Terminated |
| Reason | Zimmer is initiating a lot specific recall of the CPT Hip Stem, Versys Build-Up Block, and Trabecular Metal Reverse Glenosphere medical devices due to reports of the products being packaged in the incorrect outer carton. Product labels and patient labels are correct. |
| Root cause | Labeling mix-ups |
| Action | Zimmer sent an Urgent Medical Device Recall letter dated December 10, 2013, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to review the notification and ensure affected personnel were aware of the contents. If affected product was found, it should be quarantines and their Zimmer representative notified. The Zimmer sales representative will remove the recalled product from their facility. Customers with questions were instructed to call 1-877-946-2761. . |
| Quantity | 25 |
| Distribution | Worldwide Distribution -USA including OH, FL, WI, MI NJ, SC, CA, NC, PA, OR, WA, TN, KY, OK, KS, AZ, TX, CO, NV and Internationally to Germany. There have been 71 distribution events. Note that this product is lot controlled and may be distributed multiple times if it was returned and returned to |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K130661 | ZIMMER TRABECULAR METAL REVERSE SHOULDER SYSTEM Zimmer, Inc., May 9, 2013 |