Manta Ray" Anterior Cervical Plate (ACP) System, Intended use: The Manta Ray ACP System is an anterior cervical plate th

FDA device recall Z-2197-2011 · posted 2011-05-13 · Terminated

Recall details

Recalling firm

Integra LifeSciences Corp.

Reason for recall

Based upon the results of the firm's literature review, they determined that the Package Insert (Information for Use) and information in the Surgical Technique should be revised to include additional warnings, precautions and possible adverse events.

Action taken

The firm, Integra Spine, sent an "URGENT: FIELD CORRECTIVE ACTION" letter dated January 10, 2011 with a Field Corrective Action Acknowledgement and Return Form sent via Fed Ex/ priority mail to all customers including physicians and distributors. The letter describes the product, problem and actions to be taken. The customers were instructed to review the current inventory to identify product from the affected part numbers; replace the existing IFU (22-PI-01 rev C) with the revised IFU (22-PI-01 rev D) and the existing Surgical Technique (ST-22-001 rev A) with the revised Surgical Technique (ST-22-001 rev B), and complete and return the Field Corrective Action Acknowledgement and Return Form via fax to: 877-558-6227 or email. If you have any additional questions, contact the Manager Quality Systems Integra Spine at 330-475-8646.

Root cause

Pending

Status

Terminated

Product code

KWQ

Quantity affected

244 IFU

Distribution

Nationwide distribution: USA including states of: AL, AZ, CA, CO, FL, GA, ID. IL, KS, LA, MD, MO, NH, NM, NV, NY, OH, OK, OR, PA, PR, SD, TN, TX, UT, VA, WI, and WV.

Date initiated

2011-01-10

Date posted

2011-05-13

Date terminated

2011-10-27

Location

Plainsboro, NJ

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