Novel PEEK VBR XS 16-22 MM, S-5, 20MM, Part Number: 64733-120. Indicated for use in the thoracolumbar spine (T1 to L5) f

FDA device recall Z-0507-2009 · posted 2008-12-31 · Terminated

Recall details

Recalling firm

Alphatec Spine, Inc.

Reason for recall

Firm confirmed that two lots were mixed during manufacturing and were incorrectly labeled with the wrong part number & lot number. They were incorrectly laser marked with the wrong part numbers and sizes. Two lots were mixed from the following lot numbers: Part Number 64733-120 Lot Number 611884, and Part Number 64753-126 and Lot Number 611881.

Action taken

The recall was initiated on August 16, 2007 with Alphatec Spine contacting each of the four direct distributors by telephone. This was followed with a Product Recall Notice, dated August 27, 2007, that was mailed to all affected customers. The distributors were informed that the firm was conducting a voluntary recall because two lots were mixed during manufacturing and were incorrectly labeled with the wrong part number & lot number. The firm asked the customers to return the product, and were informed that replacement product will be sent back.

Root cause

Process control

Status

Terminated

Product code

MQP

Quantity affected

3 units

Distribution

Nationwide Distribution --- including states of AZ, FL, NY & TX.

Date initiated

2007-08-16

Date posted

2008-12-31

Date terminated

2009-01-12

Location

Carlsbad, CA