Recall Z-0558-2013
Integra LifeSciences Corporation · initiated November 5, 2012
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
MAYFIELD Composite Series Base Unit, Model A3101, a Swivel Adaptor (A3018) is an integral component of the Base Unit, Model A3101. The MAYFIELD Base Unit (A3101) is an operating room table accessory intended to be used to support a patient during diagnostic examination and/or surgical procedures where a rigid support between surgical table and headrest, or skull clamp is necessary, positional freedom is required and where X-ray imaging modalities will be used. A Swivel Adaptor (A3018) is an integral component of the Base Unit A3101.
Codes / lots: The recalle product is identified with the Lot Numbers: 097547 and 096546.
Reason for recall
An investigation of an adverse trend of complaints conducted by Integra LifeSciences identified various product performance issues which could impact the functionality of the firm's Mayfield Composite Series Base Units and Mayfield Skull Clamps. In order to prevent additional complaint reports, the firm decided to recall and replace certain lot codes of the Base Units and Skull Clamps that were d
FDA-determined cause: Under Investigation by firm
Action taken
Integra issued an 'Urgent: Voluntary Medical Device Recall Notification with 'Recall Acknowledgment and Return Form' to all Integra Sales Representatives and Customers via visit and E-mail on November 5, 2012. The recall notice informs the customers of the firm's receipt of complaints pin-pointing quality issues with the MAYFIELD Base Units and MAYFIELD Skull Clamps which may impair their functionality. The customers are asked to sign and return the enclosed Recall Acknowledgement and Return Form so as to document their receipt of the recall notification and replacement products. The replacement products are to be delivered by the Integra NeuroSpecialist who is also responsible for returning the signed forms to Integra as documentation that the recalled devices have been replaced. Should the customer(s) have questions or concerns, they are directed to contact Integra Customer Service at: 1-877-444-1114,Option 3 for Technical Support.
Details
- Recall number
- Z-0558-2013
- Initiated
- November 5, 2012
- Posted by FDA
- December 19, 2012
- Terminated
- February 21, 2014
- Product code
- FWZ – Operating Room Accessories Table Tray
- Quantity
- 5 base units were distributed
- Distribution
- Nationwide Distribution including the states of AL, AR, AZ, CA, CO, CT, FL, GA, IL, IN, KY, MA, MD, MI, MN, MO, NC, NE, NJ, NM, NY, OH, OK, OR, PA TN, TX, UT, VA, WA and WI.
- Recalling firm
- Integra LifeSciences Corporation, Cincinnati, OH
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0559-2013 Class II | MAYFIELD Composite Series Skull Clamps, Model A3059, 510(k) #K120633. The MAYFIELD Skull…An investigation of an adverse trend of complaints conducted by Integra LifeSciences identified various… | 11/05/2012Terminated |