Z-2335-2010

Abbott Spine PathFinder, Cannulated Poly Screwdriver II - MOD, non-sterile, Manufactured by Abbott Spine...

Name: Z-2335-2010 Abbott Spine PathFinder, Cannulated Poly Screwdriver II - MOD, non-sterile, Manufactured by Abbott Spine...
Creator: Zimmer Inc.
Published: 2009-01-12
License: https://open.fda.gov/license/

Zimmer GmbH / initiated 2009-01-12 / Terminated

FDA source

Zimmer Inc. began a recall of Abbott Spine PathFinder, Cannulated Poly Screwdriver II - MOD, non-sterile, Manufactured by Abbott Spine, Inc., Austin, TX; Ref. 1160-2. Usage: The screwdriver... on 2009-01-12. The reason FDA records is "The screwdriver may fracture, resulting in surgical delays and/or fragments going into the surgical site". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-2335-2010
Status: Terminated
Initiated: 2009-01-12
Posted: 2010-08-31
Terminated: 2010-12-22
Recalling firm: Zimmer GmbH
Product: 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.
Product code: MNI Orthosis, Spinal Pedicle Fixation
Reason for recall: The screwdriver may fracture, resulting in surgical delays and/or fragments going into the surgical site.
FDA root cause: Other
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.
Quantity in commerce: 691
Distribution: Worldwide.
Product codes and lots: All units. Lots 36WC, 39BA, 43MN, 44WP, 47FE, 18TH, 20XF, 25WE, 29CQ, 29YJ, 31TJ, 33ZH, 47RM, 48PC, 49QW, 51PF and 58SD.

Product code MNI

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)