Ascent POCTS (Posterior Occipital Cervical Thoracic System) Part Numbers: 65-33 XX Series (65-3310,-3312, -3314, -3318,

FDA device recall Z-0363-2008 · posted 2007-12-11 · Terminated

Recall details

Recalling firm

Blackstone Medical, Inc.

Reason for recall

Manufacturing Defect: The saddle of the screw's body relative to the keyway exceeds the tolerance outlined in the device specifications. The extent to which the tolerance is exceeded varies from part to part, in the extreme the tolerance is exceeded by (+) 50%. As a consequence, there is a potential for set-screw cross-threading during implantation. Cross-threading could in turn lead to a comprom

Action taken

Blackstone Medical, Inc., field representatives were notified via phone, e-mail or fax on 4/30/07. Attention: Notification of Product Removal Letters were sent on May 15, 2007, to distributors and implanting surgeons requesting return of non-implanted stock.

Root cause

Nonconforming Material/Component

Status

Terminated

Product code

MNI

Quantity affected

319 screws ( 212 domestic, 107 international)

Distribution

Worldwide: USA and countries of China, Cyprus, Turkey and Switzerland.

Date initiated

2007-05-15

Date posted

2007-12-11

Date terminated

2008-06-06

Location

Wayne, NJ