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.
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