—#115508

Product

MAYFIELD Composite Series Base Unit Standard, Model (A3101), Rx ONLY, Integra LifeScience Corporation, 4900 Charlemar Drive, Building A, Cincinnati, OH 45227 The MAYFIELD Base Units are 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.

FDA product code: FWZ — Operating Room Accessories Table Tray
Device class: Class 1
Medical specialty: General, Plastic Surgery
Affected lot / code info: Model # A3101 Base Units Serial No's: SB120016, SB120017, SB120019, SB120020, SB120021, SB120022, SB120023, SB120024, SB120025, SB120026, SB120027, SB120028, SB120029, SB120030, SB120031, SB120032, SB120134, SB120036, SB120037, SB120038, SB120040, SB120042, SB120043, SB120044, SB120045, SB120049, SB120050, SB120051, SB120052, SB120053, SB120054, SB120055, SB120056, SB120057, SB120058, SB120059, SB120060, SB120061, SB120062, SB120063, SB120064, SB120065, SB120066, SB120067, SB120068, SB120069, SB120070, SB120071, SB120072, SB120073, SB120074, SB120075, SB120076, SB120077, SB120078, SB120079, SB120080, SB120081, SB120082, SB120083, SB120084, SB120085, SB120086, SB120087, SB120088, SB120089, SB120090, SB120091, SB120092, SB120093, SB120094, SB120095, SB120096, SB120097, SB120098, SB120099, SB120100, SB120107, SB120108, SB120109, SB120111, SB120112, SB120113, SB120114, SB120115, SB120116, SB120117, SB120118, SB120119, SB120120, SB120121, SB120122, SB120129, SB120131, SB120138 & SB120141.

Why it was recalled

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

Root cause (FDA determination)

Device Design

Action the firm took

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

Recalling firm

Firm: Integra LifeSciences Corp.
Address: 311 Enterprise Dr, Plainsboro, New Jersey 08536-3344

Distribution

Distribution pattern: 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.

Timeline

Recall initiated: 2012-12-21
Posted by FDA: 2013-02-21
Terminated: 2013-07-10
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #115508. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.