—#86324

Product

Zimmer/CAS Power Cord, Sesamoid Plasty, NA, Zimmer/CAS, Montreal (Quebec), Canada; REF 20-8000-070-12. The device is the power cord component for the Sesamoid Plasty CAS workstation which connects the workstation to the power mains.

FDA product code: HAW — Neurological Stereotaxic Instrument
Device class: Class 2
Medical specialty: Neurology
510(k) numbers: K060336, K071714, K071929
Affected lot / code info: Workstation serial numbers SP014, SP015, SP019 through SP022, SP025 through SP033, SP035, SP038, SP039, SP043, SP044, SP047, SP049, SP052, SP057, SP058, SP060, SP061, SP062, SP064, SP065, SP069, SP072, SP074 through SP083, SP089, SP090, SP091, SP093, SP094, SP098, SP099, SP121, SP124, SP125, SP127, SP128, SP131 through SP135, SP151 through SP154, SP157, SP175, SP176, SP183, SP184, SP185, SP190 and SP198.

Why it was recalled

The power cord female receptacle is not recessed sufficiently and may present a shock hazard.

Root cause (FDA determination)

Device Design

Action the firm took

Zimmer sales staff were notified by letter dated 11/2/09 and instructed to locate the units and to upgrade the cords and to notify consignees by copy of a letter addressed to risk managers and dated 11/2/09.

Recalling firm

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

Distribution

Distribution pattern: Nationwide.

Timeline

Recall initiated: 2009-11-02
Posted by FDA: 2009-12-22
Terminated: 2010-10-15
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #86324. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.