One-level Ant-Cer Plates (Assembly Level). 1706-1024, 1706-1026, 1706-1028, 1706-1030, 1706-1032, and product literature. Devices are manufactured by Spinal Concepts, Inc., An Abbott Laboratories Company
FDA Recall Z-0807-04 · Posted 2004-07-20
Advertisement
Recalling FirmSpinal Concepts, Inc
Recall StatusTerminated
Product CodeKWQ
Date Initiated2004-03-01
Date Terminated2007-04-13
Product Quantity15 (1706-1024); 14 (1706-1026); 17 (1706-1028); 8 (1706-1030); 8 (1706-1032); and 25 (1757-1)
Reason for Recall
Design has insufficient articulating distance between the two component plates to prevent disassociation in vivo.
Firm Action
The firm initiated the recall via telephone on 03/01/2004 to all distributors followed up by recall letter on 03/05/2004.
Root Cause
Other
Distribution Pattern
Nationwide
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
Advertisement