—#95899

Product

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.

FDA product code: HSB — Rod, Fixation, Intramedullary And Accessories
Device class: Class 2
Medical specialty: Orthopedic
510(k) numbers: K091566
Affected lot / code info: Lot Numbers: 00111903 and 07890923.

Why it was recalled

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 (FDA determination)

Nonconforming Material/Component

Action the firm took

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.

Recalling firm

Firm: Zimmer Inc.
Address: 345 E Main St, Warsaw, Indiana 46580-2746

Distribution

Distribution pattern: 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.

Timeline

Recall initiated: 2010-10-29
Posted by FDA: 2010-12-28
Terminated: 2011-09-16
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #95899. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.