Circular Lock Screws, part # G826, lot # 11406. The Lock Screws are part of the Genesys Spine TiLock Pedicle Screw Syste

FDA device recall Z-2677-2014 · posted 2014-09-22 · Terminated

Recall details

Recalling firm

Genesys Orthopedics Systems, LLC

Reason for recall

The recall is being initiated because MK Precision (the Circular Lock Screw supplier) notified Genesys Spine that a portion (less than 20%) of the Circular Lock Screws in lot 11406 were manufactured using Stainless Steel in the center Post instead of the specified titanium alloy.

Action taken

Genesys Spine sent an Urgent Medical Device Recall letter dated April 2, 2014, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to immediately examine their inventory and quarantine any affected product. Customers were instructed to notify their customers (end users) of the recall and request that they return any affected product to Genesys Spine by completing the attached Recall Tracking Form to Genesys Spine, 1250 South Capital of Texas Hwy, Building Three, Suite 600, Austin, Texas 78746. Customers with questions were instructed to call 512-381-7070.

Root cause

Nonconforming Material/Component

Status

Terminated

Product code

NKB

Quantity affected

642

Distribution

Nationwide Distribution including NV, CA, NY, MO, TX, FL, NJ, GA, TN.

Date initiated

2014-04-02

Date posted

2014-09-22

Date terminated

2015-05-15

Location

Austin, TX

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