Recall Z-2197-2011 ยท KWQ Appliance, Fixation, Spinal Intervertebral Body
Integra LifeSciences Corp.
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.
| Date | May 13, 2011 (initiated Jan 10, 2011) |
| Status | Terminated |
| Reason | 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 | Pending |
| Action | 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 ( |
| Quantity | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K080690 | MANTA RAY ANTERIOR CERVICAL PLATE SYSTEM Theken Spine, LLC, Apr 25, 2008 |