ATLANTIS (R) Self-Tapping Variable Angle Screw, Rx only, Medtronic Sofamor Danek USA, 1800 Pyramid Place, Memphis, TN 38

FDA device recall Z-2878-2011 · posted 2011-07-25 · Terminated

Recall details

Recalling firm

Medtronic Sofamor Danek USA Inc

Reason for recall

Screws are longer then size etched on the screw.

Action taken

Medtronic sent a Voluntary Recall letter dated June 28, 2011, directly to Risk Managers and Sales Representatives, with Recall Questionnaires and Confirmation forms included. The letter identified the product, the problem, and the action to be taken by the affected customers. If appropriate, personal follow up with Sales Representatives will be made to assure that the recall communication is understood by Risk Managers and to facilitate return of product and the associated Recall response documentation. Foreign consignees will be notified by email on June 29, 2011. For any questions or concerns regarding this recall customers were to contact their Medtronic Sales Representative or the Global Quality Department at 800-876-3133, ext 3173.

Root cause

Other

Status

Terminated

Product code

KWP

Quantity affected

101 units

Distribution

Worldwide Distribution - USA (nationwide) and the countries of MN, AK, FL, PA, ME, GA HI, CA, TX, OH, IN, MO, WI, MI, NY, IN, LA, MD, MA, NC, OR, NE WA, ID, CO, OR, UT, IL, WV, Canada, Singapore, Neth

Date initiated

2011-06-28

Date posted

2011-07-25

Date terminated

2012-12-24

Location

Memphis, TN

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