Synthes Zero-P StarDrive Screwdriver Shaft, T8, self-retaining, quick coupling, for use in spinal fusion surgery. Catalo

FDA device recall Z-1348-2009 · posted 2009-06-10 · Terminated

Recall details

Recalling firm

Synthes Spine

Reason for recall

Tip breakage, due to inadequate instructions for use. The Technique Guide provided incorrect information related to use of the Torque Limiting Attachment during screw insertion and final tightening.

Action taken

All affected Synthes Spine Sales Consultants were notified of the Labeling Correction via email on February 10, 2009. They were instructed to review changes with their surgeons. They were supplied with an electronic version of the corrected Technique Guide on March 11, 2009. All affected Synthes Sales Consultants and Customers were notified of this labeling change via distribution of the updated Technique Guide and a notification letter. This packet was sent via USPS certified mail on March 26, 2009. To ensure a broad and accurate distribution of notification, affected consultants and customers are defined as having been shipped Zero-P 3.0 mm Titanium Cervical Spine Locking Screws. These devices are used only with the Zero-P system.

Root cause

Labeling design

Status

Terminated

Product code

ODP

Quantity affected

1766 units

Distribution

Distributed Nationwide and Canada.

Date initiated

2009-02-10

Date posted

2009-06-10

Date terminated

2009-10-05

Location

West Chester, PA

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