Atlas FDA

Zimmer Cannulated Screw System Cannulated Driver, 5.0 mm Hex, REF 1147-49-50; Catalog # 00-1147-049-50. Manufactured by

FDA device recall Z-0872-06 · posted 2006-05-18 · Terminated

Recall details

Recalling firm
Pioneer Surgical Technology
Reason for recall
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.
Action taken
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.
Root cause
Other
Status
Terminated
Product code
HWC
Quantity affected
74
Distribution
Nationwide.
Date initiated
2006-03-03
Date posted
2006-05-18
Date terminated
2007-12-04
Location
Marquette, MI

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Related 510(k) clearances

RecordFirmDate
CANNULATED SCREW SYSTEM (K003496)Pioneer Surgical Technology2001-02-08