Manta Ray: Anterior Cervical Plate (ACP) System, 510 (k) #K080690. The labeling for the plate component reads in part: '

FDA device recall Z-0087-2011 · posted 2010-10-19 · Terminated

Recall details

Recalling firm

Theken Spine Llc

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.

Action taken

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.

Root cause

Other

Status

Terminated

Product code

KWQ

Quantity affected

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.

Date initiated

2010-07-29

Date posted

2010-10-19

Date terminated

2012-09-21

Location

Akron, OH

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