Recall Z-0824-2011 ยท HSB Rod, Fixation, Intramedullary And Accessories
Zimmer Inc.
Zimmer Natural Nail System Cephalomedullary Lag Screw Inserter Long, Catalog 00-2490-003-50, Zimmer, Warsaw, IN. A reusable surgical instrument used for the insertion of a Lag Screw used in the Zimmer Natural Nail system.
| Date | Dec 28, 2010 (initiated Oct 29, 2010) |
| Status | Terminated |
| Reason | The firm has determined that two lots of this instrument were inappropriately manufactured by the supplier. The manufacturing process created a step in the lumen which impedes the Lag Screw Retaining Shaft from passing through the lumen without the use of excessive force. |
| Root cause | Nonconforming Material/Component |
| Action | The firm sent Correction and Removal Notification Immediate Response Required letters via email to consignees. The letter identified the affected product and the reason for the recall. The letters also discussed the clinical implications and required actions. Customers are to complete the inventory certification form and user facility documentation form. Each of the affected accounts will be provided with a new instrument, manufactured with the correct lumen diameter and will secure and return the affected instruments per the attached notification, along with the completed inventory certif |
| Quantity | 34 |
| Distribution | Worldwide Distribution -- USA, including states of MI, NJ, MS, OR, KS, TN, A, UT, and CA and countries of Belgium and Germany, Spain, Italy, Greece, France, UK, and Switzerland. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K091566 | ZIMMER NATURAL NAIL SYSTEM CEPHALOMEDULLARY NAILS Zimmer GmbH, Oct 28, 2009 |