—#86568

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.

FDA product code: MNI — Orthosis, Spinal Pedicle Fixation
Device class: Class 2
Medical specialty: Orthopedic
510(k) numbers: K030625, K071174
Affected lot / code info: All units. Lots 36WC, 39BA, 43MN, 44WP, 47FE, 18TH, 20XF, 25WE, 29CQ, 29YJ, 31TJ, 33ZH, 47RM, 48PC, 49QW, 51PF and 58SD.

Why it was recalled

The screwdriver may fracture, resulting in surgical delays and/or fragments going into the surgical site.

Root cause (FDA determination)

Other

Action the firm took

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.

Recalling firm

Firm: Zimmer Inc.
Address: 345 E Main St, Warsaw, Indiana 46580-2746

Distribution

Distribution pattern: Worldwide.

Timeline

Recall initiated: 2009-01-12
Posted by FDA: 2010-08-31
Terminated: 2010-12-22
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #86568. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.