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U.S. Department of Health and Human Services

Class 2 Device Recall Manta Ray ACP System

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  Class 2 Device Recall Manta Ray ACP System see related information
Date Initiated by Firm July 29, 2010
Date Posted October 19, 2010
Recall Status1 Terminated 3 on September 21, 2012
Recall Number Z-0087-2011
Recall Event ID 56502
510(K)Number K080690  
Product Classification Appliance, fixation, spinal intervertebral body - Product Code KWQ
Product 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 Cervical Plate (ACP) System is intended for temporary stabilization of the cervical spine C2-C7 due to the following indications: DDD (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); Spondylolisthesis; Trauma (i.e. fracture/dislocation); Tumor; Spinal stenosis; Deformity (i. e. scoliosis, kyphosis and/or lordosis); Pseudoarthrosis; and Failed previous fusion.
Code Information A total of 136 Catalog Numbers of the suspect device were affected by the firm's corrective action. They are as follows:   22-10-0118 22-10-0366 22-12-4016 22-17-4515 22-20-0351 22-21-4017 22-10-0120 22-10-0369 22-12-4018 22-17-4517 22-20-0354 22-21-4018 22-10-0122 22-10-0372 22-13-4513 22-18-4513 22-20-0357 22-22-4511 22-10-0124 22-10-0375 22-13-4515 22-18-4515 22-20-0360 22-22-4513 22-10-0126 22-10-0468 22-13-4517 22-18-4517 22-20-0363 22-22-4515 22-10-0128 22-10-0472 22-14-4513 22-20-0118 22-20-0366 22-22-4517 22-10-0130 22-10-0476 22-14-4515 22-20-0120 22-20-0369 22-22-4519 22-10-0132 22-10-0480 22-14-4517 22-20-0122 22-20-0372 22-23-4010 22-10-0134 22-10-0484 22-15-4010 22-20-0124 22-20-0375 22-23-4011 22-10-0231 22-10-0488 22-15-4012 22-20-0126 22-20-0468 22-23-4012 22-10-0234 22-10-0492 22-15-4013 22-20-0128 22-20-0472 22-23-4013 22-10-0237 22-11-4010 22-15-4014 22-20-0130 22-20-0476 22-23-4014 22-10-0240 22-11-4012 22-15-4015 22-20-0132 22-20-0480 22-23-4015 22-10-0243 22-11-4013 22-15-4016 22-20-0134 22-20-0484 22-23-4016 22-10-0246 22-11-4014 22-15-4018 22-20-0231 22-20-0488 22-23-4017 22-10-0249 22-11-4015 22-16-4010 22-20-0234 22-20-0492 22-23-4018 22-10-0252 22-11-4016 22-16-4012 22-20-0237 22-21-4010 22-24-4511 22-10-0348 22-11-4018 22-16-4013 22-20-0240 22-21-4011 22-24-4513 22-10-0351 22-12-4010 22-16-4014 22-20-0243 22-21-4012 22-24-4515 22-10-0354 22-12-4012 22-16-4015 22-20-0246 22-21-4013 22-24-4517 22-10-0357 22-12-4013 22-16-4016 22-20-0249 22-21-4014 22-24-4519 22-10-0360 22-12-4014 22-16-4018 22-20-0252 22-21-4015  22-10-0363 22-12-4015 22-17-4513 22-20-0348 22-21-4016  
Recalling Firm/
Manufacturer		 Theken Spine Llc
1800 Triplett Blvd
Akron OH 44306-3311
For Additional Information Contact
609-275-0500
Manufacturer Reason
for Recall		 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.
FDA Determined
Cause 2		 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 that each customer: 1) received the technical bulletin; and 2) has read and understood the proper technique for surgical placement of the screws as outlined in the bulletin. For technical support customers were to contact the Customer Service Department at (866) 942-8698.
Quantity in Commerce 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = KWQ and Original Applicant = THEKEN SPINE LLC
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