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.
Recall
- Recall Number
- Z-0824-2011
- Event Number
- 57341
- Firm
- Zimmer Inc.
- FEI Number
- 1000220733
- Product Code
- HSB
- Status
- Terminated
- Root Cause
- Nonconforming Material/Component
- Initiated
- October 29, 2010
- Posted
- December 28, 2010
- Terminated
- September 16, 2011
- Address
- 345 E Main St, Warsaw, IN, 46580-2746
Description
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.
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.
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 certification form. If any further information is needed, customers are to contact Aimee Wood at 574-372-4463.
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.
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