Abbott Spine PathFinder, Cannulated Poly Screwdriver II - MOD, non-sterile, Manufactured by Abbott Spine, Inc., Austin, TX; Ref. 1160-2. Usage: The screwdriver is intended to mate to the hexalobular feature of a PathFinder open polyaxial screw and threads onto the head to hold it in on-axis for implanting.
FDA Recall Z-2335-2010 · Posted 2010-08-31
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Recalling FirmZimmer Inc.
Recall StatusTerminated
Product CodeMNI
Date Initiated2009-01-12
Date Terminated2010-12-22
Product Quantity691
Reason for Recall
The screwdriver may fracture, resulting in surgical delays and/or fragments going into the surgical site.
Firm Action
The sales force was provided with new instructions for use on 1/12/09 and again in 05/09. On April 6, 2010 the firm sent out an Urgent Medical Device Correction to it's field representatives for distribution to it's customers. The field representatives were to distribute the forms and provide a list of the customers that recieved the recall notice.
For questions or assistance, please contact Zimmer Spine at 800-326-0635.
Root Cause
Other
Distribution Pattern
Worldwide.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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