Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-1481-2009

Zimmer Steinmann Pins, 7/64 in. (2.8 mm) diameter, 9 in. (229mm) length, style 6, nonsterile, qty 6, Zimmer...

Zimmer GmbH / initiated 2009-05-01 / Terminated / root cause: packaging

Zimmer Inc. began a recall of Zimmer Steinmann Pins, 7/64 in. (2.8 mm) diameter, 9 in. (229mm) length, style 6, nonsterile, qty 6, Zimmer, Warsaw, IN; Model Number: 00-0187-03-69. Steinmann... on . The reason FDA records is "The package contains pins with an incorrect diameter". As of , the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number
Z-1481-2009
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Zimmer GmbH
Product
Zimmer Steinmann Pins, 7/64 in. (2.8 mm) diameter, 9 in. (229mm) length, style 6, nonsterile, qty 6, Zimmer, Warsaw, IN; Model Number: 00-0187-03-69. Steinmann Pins are utilized in skeletal traction for alignment and reduction of long bone fractures as guide wires in hip pinning and for fracture alignment in certain other types of fractures.
Product code
HTY Pin, Fixation, Smooth
Reason for recall
The package contains pins with an incorrect diameter.
Root cause tag
packaging
FDA root cause
Packaging process control
Action
Zimmer, Inc. issued an "Urgent: Device Recall" letter informing users of the affected product. Users were instructed to locate and quarantine all unused devices and ship them to the firm with a completed Inventory Return Certification form. Return Certification forms are also to be sent via fax to Zimmer, Inc. at 1-574-372-4265. For further questions, contact Zimmer, Inc. at 1-800-613-6131.
Quantity in commerce
37
Distribution
Worldwide Distribution -- US including states of CA, GA, IL, MA, MO, OR, TX and WI and Japan.
Product codes and lots
Lot Number: 61156235.