—#84202

Product

Zimmer / Abbott Spine Sequoia dorsal height & revision tool, non-sterile; REF 3367-1. Surgical instrument for pedicle screw system.

FDA product code: NKB — Thoracolumbosacral Pedicle Screw System
Device class: Class 2
Medical specialty: Orthopedic
510(k) numbers: K082032
Affected lot / code info: Lots 47PN, 47PP, 49HK, 49HL and 57WL.

Why it was recalled

The tip of the instrument may fracture during use.

Root cause (FDA determination)

Device Design

Action the firm took

Zimmer sent a letter dated 8/17/09 to distributors and consignees on or about 8/20/09. Users were notified of the potential problem via the letter and advised that the instruments will be removed and replaced when a new version of the instrument becomes available (around 10/09).

Recalling firm

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

Distribution

Distribution pattern: Nationwide, Belgium and New Zealand.

Timeline

Recall initiated: 2009-08-20
Posted by FDA: 2009-12-22
Terminated: 2011-04-13
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #84202. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.