ORTHOFIX Firebird Spinal Fixation System, Pedicle Screw Spinal System, Reduction Case, Part #68-0111, Lot #16518-LC18. I

FDA device recall Z-1608-2011 · posted 2011-03-08 · Terminated

Recall details

Recalling firm

Orthofix Inc

Reason for recall

There is a possibility that certain Anti-Splay Caps may not mate properly during assembly of the construct to the Screw Body with Multi-Axial Reduction Screw Assemblies.

Action taken

The firm, Orthofix, sent an "URGENT: PRODUCT RECALL" letter dated October 22, 2010 to all customers. The letter describes the product, problem and the action to be taken by the customers. The customers were instructed to: 1) identify and remove the affected product 2) complete the enclosed Tracking and Verification Form via fax to: Orthofix Inc. at 214-937-2764, and 3) contact their Account Services Representative at 1-888-298-5700 and obtain a return authorization number to return product to Orthofix, Inc. The letter also states that Orthofix Inc., will provide replacement Anti-Splay Caps via priority delivery. If you have any questions regarding the removal and return of this product to Orthofix Inc., please contact your Account Service Representative at 1-888-298-5700. Should you have any other questions or concerns, please contact the Director of Regulatory Affairs at 214-937-2061 or by email: DarlaChew@Orthofix.com.

Root cause

Other

Status

Terminated

Product code

NKB

Quantity affected

166 Units

Distribution

Nationwide distribution: USA including states of: CA, CO, FL, LA , MD, MI, MO, NJ, NY, OH, TN, VA, and WA.

Date initiated

2010-10-22

Date posted

2011-03-08

Date terminated

2011-04-25

Location

Lewisville, TX

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