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Zimmer Natural Nail System Cephalomedullary Lag Screw… recallZ-0824-2011 · Zimmer Inc. · initiated Oct 29, 2010

Terminated All recalls posted in December 2010

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Zimmer Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

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.

FDA root cause category: Nonconforming Material/Component

What the company is doing

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.

Recall details

Recall number
Z-0824-2011
Recall class
Not yet classified by the FDA
Status
Terminated
Initiated by the company
Oct 29, 2010
Posted by the FDA
Dec 28, 2010
Recalling firm
Zimmer Inc.
Quantity
34
Product code
HSB
FDA submissions
K091566
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.

Product 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.

Code information (models, lots, serial numbers)

Lot Numbers: 00111903 and 07890923.

Other devices under the same FDA submission

10 devices cleared under K091566 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Sources and updates

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