Recall Z-0071-2011 ยท LXH Orthopedic Manual Surgical Instrument
Zimmer Inc.
Continuum Acetabular Systems Shell Inserter Adapter with Rotational Control, 00-8790-003-00, Zimmer Inc., Warsaw, IN. Used to mate the inserter with the shell implant.
| Date | Oct 15, 2010 (initiated Mar 19, 2010) |
| Status | Terminated |
| Reason | The firm has received reports of users encountering difficulties in usage leading to surgical delays or minor damage to a threaded surface of the shell implant. |
| Root cause | Device Design |
| Action | The firm sent Urgent: Device Removal letters dated 3/15/2010. The letter identified the affected product, described the issue, discussed the clinical implications, and provided a list of required actions. The consignees were instructed to perform an inventory of the recalled product and report the amount on hand to Zimmer by completing the Inventory Return Certification Form. After Zimmer received the report, they would send out new product to the consignee. After new product was received the consignees were instructed to return the recalled product to Zimmer. The firm expects to have all |
| Quantity | 1125 all products |
| Distribution | Worldwide Distribution -- US, Singapore, Australia, Portugal, Germany, Switzerland, Spain, Finland, United Kingdom, Israel, Italy and Sweden. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K091508 | ZIMMER CONTINUUM ACETABULAR SYSTEM, ZIMMER TRILOGY IT ACETABULAR SYSTEM Zimmer, Inc., Sep 11, 2009 |