Sequoia final driver closure top retention, non-sterile, REF 3384-2, Zimmer Spine, Austin, Texas, The device is used to

FDA device recall Z-2705-2011 · posted 2011-06-29 · Terminated

Recall details

Recalling firm

Zimmer Inc.

Reason for recall

A rounded or partially rounded tip on the screwdriver may not provide the required locking torque to lock the closure top to the polyaxial screw. When the hex tip of the screwdriver is not fully engaged and/or the screwdriver is used off axis, the hex tip of the screwdriver can become rounded or partially rounded.

Action taken

The firm, ZIMMER, sent an "URGENT MEDICAL DEVICE RECALL" letter dated April 4, 2011 to its customers. The letter described the product, problem and actions to be taken. The customers were instructed to ensure that each instrument tray had both final drivers (with and without retention feature); contact their customer service representative if they do not have both versions; ensure proper seating of the drive by moving the driver side to side, and complete and return the Distributor Certification Form via fax to: Zimmer Spine at 512-258-0995. The letter states the firm will be distributing the version of the screwdriver with no retention feature beginning in March 2011 and distributing the new surgical technique in April 2011. The firm is including an additional final driver in the instrument tray for final tightening of the closure tops. Please keep Zimmer Spine informed of any adverse events associated with the device or any other Zimmer spine product by calling 800-326-0635. For any further questions or concerns contact the Vice President Quality Assurance & Regulatory Affairs at 800-655-2614.

Root cause

Device Design

Status

Terminated

Product code

HAO

Quantity affected

505 devices

Distribution

Worldwide distribution: USA (nationwide) including the states of: AL, AZ, CA, CT, CO, FL, GA, LA, MI, MN, MO, NC, NY, OH, OK, PA, TN, TX, WA and WI; and countries of: Czech Republic, Denmark, France,

Date initiated

2011-04-04

Date posted

2011-06-29

Date terminated

2013-08-28

Location

Warsaw, IN

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