Recall Z-0087-2011 ยท KWQ Appliance, Fixation, Spinal Intervertebral Body
Theken Spine Llc
Manta Ray: Anterior Cervical Plate (ACP) System, 510 (k) #K080690. The labeling for the plate component reads in part: 'REF: 22-'**** MAT'L: Titanium per ASTM F-136, Lot: W****, Description: Plate - 40 mm, Qty: 1.' The labeling for the screw component reads in part: 'REF: 22-**** MAT'L: Titanium per ASTM F-136 LOT W**** Description: Screw-Fixed Tapping 4x10mm QTY: 1. Manta Ray Anterior C
| Date | Oct 19, 2010 (initiated Jul 29, 2010) |
| Status | Terminated |
| Reason | The Manta Ray Cervical System was subject to corrective action by the firm after two (2) customer complaints were received alleging that screws were 'backing out' of the device during surgical procedures. |
| Root cause | Other |
| Action | Integra sent a Technical Bulletin dated July 29, 2010 via Fedex to their customers. The bulletin identified the product, the problem, and action to be taken by the user/customers (surgeons) of the two (2) reported instances of screws backing out of the plates. The Bulletin provided instructions outlining the proper surgical techniques for implantation of screws using the Manta Ray ACP System. The bulletin also included an attached acknowledgement form which the user/customers were asked to complete and FAX to (609) 275-5363 or E-mail back to the E-mail address provided. The form verified t |
| Quantity | 1081- includes totals distributed for both plates & screws |
| Distribution | Nationwide Distribution - USA including AL, AZ, CA, CT, FL, GA, HI, IL, ID, IN, KS, LA, MI, MD, MN, MA, MD, MS, NE, NY, NC, NJ, NV, NM, OH, OR, OK, PA, TN, TX, UT, WI, and WA.WA. |
| 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 |