—#98587

Product

Manta Ray" Anterior Cervical Plate (ACP) System, Intended use: The Manta Ray ACP System is an anterior cervical plate that is indicated for temporary stabilization of the cervical spine from C2-C7.

FDA product code: KWQ — Appliance, Fixation, Spinal Intervertebral Body
Device class: Class 2
Medical specialty: Orthopedic
510(k) numbers: K080690
Affected lot / code info: Part Numbers: 22-10-0118, 22-10-0120, 22-10-0122, 22-10-0124, 22-10-0126, 22-10-0128, 22-10-0130, 22-10-0132, 22-10-0134, 22-10-0231, 22-10-0234, 22-10-0237, 22-10-0240, 22-10-0243, 22-10-0246, 22-10-0249, 22-10-0252, 22-10-348, 22-10-0351, 22-10-0354, 22-10-0357, 22-10-0360, 22-10-0363, 22-10-0366, 22-10-0369, 22-10-0372, 22-10-0375, 22-10-0468, 22-10-0472, 22-10-0476, 22-10-0480, 22-10-0484, 22-10-0488, 22-12-4014, 22-12-4015, 22-12-4016, 22-12-018, 22-13-4513, 22-13-4515, 22-13-4517, 22-14-4513, 22-14-4515, 22-14-4517, 22-15-4010, 22-15-4012, 22-15-4013, 22-15-4014, 22-15-4015, 22-15-4016, 22-5-4018, 22-16-4010, 22-16-4012, 22-16-4013, 22-16-4014, 22-16-4015, 22-16-4016, 22-16-4018, 22-17-4513, 22-17-4515, 22-17-4517, 22-18-4513, 22-18-4515, 22-18-4517, 22-20-0118, 22-20-0120, 22-20-0122, 22-20-0124, 22-20-0126, 22-20-0128, 22-20-0130, 22-20-0132, 22-20-0134, 22-20-0231, 22-20-0234, 22-20-0237, 22-20-0240, 22-20-0243, 22-20-0246, 22-20-0249, 22-20-0252, 22-20-0348, 22-20-0351, 22-20-0354, 22-20-0357, 22-20-0360, 22-20-0363, 22-20-0366, 22-20-0369, 22-20-0372, 22-20-0375, 22-20-0468, 22-20-0472, 22-20-0476, 22-20-0480, 22-20-0484, 22-20-0488, 22-20-0492, 22-21-4010, 22-21-4011, 22-21-4012, 22-21-4013 & 22-21-4014.

Why it was recalled

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.

Root cause (FDA determination)

Pending

Action the firm took

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.

Recalling firm

Firm: Integra LifeSciences Corp.
Address: 311 Enterprise Dr, Plainsboro, New Jersey 08536-3344

Distribution

Distribution pattern: 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.

Timeline

Recall initiated: 2011-01-10
Posted by FDA: 2011-05-13
Terminated: 2011-10-27
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #98587. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.