Recalls / —

—#81682

Product

Zimmer Dynesys top-loading cutter, spacer, Zimmer Spine, Minneapolis, MN; REF 07.01284.001.

FDA product code

NQP — Posterior Metal/Polymer Spinal System, Fusion

Device class

Class 2

Medical specialty

Orthopedic

510(k) numbers

K073347

Affected lot / code info

All lots. Lots 60859166, 60859167, 61085708. 60970745, 61024375, 61024376 and 61123514.

Why it was recalled

The spacer cutter may jam during surgery, preventing use of the instrument and causing surgical delay.

Root cause (FDA determination)

Other

Action the firm took

Consignees were notified by letter dated 5/20/09 titled "Urgent Medical Device Correction" that instructed customers that they may continue to use the recalled product until adequate replacements become available, but that they should always ensure they have a backup spacer cutter (of a different model which does not have this issue) available in case this model should jam during use. Users were also advised to ensure the spacer cutter is properly lubricated and is sharp. For questions, please contact Zimmer Spine at 1-800-777-7505.

Recalling firm

Firm

Zimmer Inc.

Address

345 E Main St, Warsaw, Indiana 46580-2746

Distribution

Distribution pattern

Nationwide, Austria, Belgium, Canada, Italy, Netherlands, Singapore, Spain, Switzerland and United Kingdom.

Timeline

Recall initiated

2009-05-28

Posted by FDA

2009-11-19

Terminated

2011-10-05

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #81682. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.