Ascent POCTS (Posterior Occipital Cervical Thoracic System) Part Numbers: 65-33 XX Series (65-3310,-3312, -3314, -3318, -3320-, -3322, -3324, -3326, -3328, and -3330), Multi-Axial Screw, 4.0mm x 26mm;Implant grade Titanium Alloy; Blacksone Medical Inc., 90 Brookdale Drive, Springfield, MA 01104.
This recall has been terminated (originally issued December 11, 2007).
- Company
- Blackstone Medical, Inc.
- Recall Initiated
- May 15, 2007
- Posted
- December 11, 2007
- Terminated
- June 6, 2008
- Recall Number
- Z-0363-2008
- Quantity
- 319 screws ( 212 domestic, 107 international)
- Firm Location
- Wayne, NJ
- Official Source
- View on FDA website ↗
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
Distribution
Worldwide: USA and countries of China, Cyprus, Turkey and Switzerland.
Lot / Code Info
Part Numbers: 65-3310,-3312, -3314, -3318, -3320-, -3322, -3324, -3326, -3328, and -3330; Lot numbers: 009, 010, 011, 018, 019, 031, 048, 064, 084 and 107.
Root Cause
Nonconforming Material/Component
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.