MAYFIELD Composite Series Base Unit Standard, Model (A3101), Rx ONLY, Integra LifeScience Corporation, 4900 Charlemar Dr

FDA device recall Z-0869-2013 · posted 2013-02-21 · Terminated

Recall details

Recalling firm

Integra LifeSciences Corp.

Reason for recall

Integra determined there is a possibility that the Base Units may break during use.

Action taken

Integra LifeSciences Corporation sent an Urgent Medical Device Recall letter dated December 21, 2012, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to stop using the affected product immediately and also remove them from service to prevent any further use of the affected product. Integra would provide an alternative base unit to replace those customers could no longer use. Customers were asked to complete the Recall Acknowledgement and Return Form to ensure they received this information. For assistance customers were instructed to call 1-513-533-7944 or 1-513-533-7946

Root cause

Device Design

Status

Terminated

Product code

FWZ

Quantity affected

96 units

Distribution

Worldwide Distribution - USA including AL, AR, AZ, CA, CO, CT, FL, GA, IL, IN, KY, MA, MD, MI, MN, MO, MS, NC, NE, NJ, NM, NY, OH, OK, OR, PA, TN, TX, UT, VA, WA & WI. Internationally to Belgium.

Date initiated

2012-12-21

Date posted

2013-02-21

Date terminated

2013-07-10

Location

Plainsboro, NJ