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Zimmer Cannulated Screw System Cannulated Driver, 5.0 mm… recallZ-0872-06 · Pioneer Surgical Technology · initiated Mar 3, 2006

Terminated All recalls posted in May 2006

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 Pioneer Surgical Technology 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

There may be an obstruction in the cannula that will prevent the guide wire from passing through it. The obstruction in the cannula can force the guidewire to advance further into the patient than intended.

FDA root cause category: Other

What the company is doing

Pioneer notified Zimmer via letter dated 3/3/06 and Zimmer notified their hospital customers and distribution sites via letters dated 3/10/06 to check their inventory and return the product immediately to Zimmer.

Recall details

Recall number
Z-0872-06
Recall class
Not yet classified by the FDA
Status
Terminated
Initiated by the company
Mar 3, 2006
Posted by the FDA
May 18, 2006
Recalling firm
Pioneer Surgical Technology
Quantity
74
Product code
HWC
FDA submissions
K003496
Distribution
Nationwide.

Product description

Zimmer Cannulated Screw System Cannulated Driver, 5.0 mm Hex, REF 1147-49-50; Catalog # 00-1147-049-50. Manufactured by Pioneer Surgical Technology, Marquette, MI; Distributed by Zimmer, Warsaw, IN.

Code information (models, lots, serial numbers)

Lots 51198300, 51217200, 51234800, 51260000 and 51302600.

Other devices under the same FDA submission

1 device cleared under K003496 — 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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