INFUSE(R) Bone Graft, MEDIUM KIT, REF 7510400, Medtronic Sofamore Danek USA, Inc., 1800 Pyramid Place, Memphis, Tennesse

FDA device recall Z-1590-2013 · posted 2013-06-25 · Terminated

Recall details

Recalling firm

Medtronic Sofamor Danek USA Inc

Reason for recall

Kits contain a collagen sponge recalled by Integra due to possible elevated endotoxin levels resulting from a process deviation.

Action taken

Medtronic on behalf of Integra LifeSciences Corporation sent an Urgent Voluntary Removal (Recall) letter on May 24, 2013, directly to all Risk Managers and Sales Representatives, with Recall Questionnaires and Confirmation forms included. Foreign consignees were notified by email on May 28, 2013. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to remove the product and discontinue use. The letter should be forwarded to surgeons or attending physicians who have used the affected products. Customers were instructed to use the attached questionnaire to account for product in their possession, document which physicians they notified and report any patient injuries that may have occurred related to the use of the affected product by calling the phone number in the questionnaire. Customers were asked to return the questionnaire using the enclosed self-addressed stamped envelope, via their Medtronic Sales Representative or via fax to 763-367-8134 For questions regarding this recall 901-399-3182. Customers were instructed to contact their Medtronic Sales Representative to coordinate the return and replenishment of affected product . Customers with questions should call 800-876-3133, ext 3197.

Root cause

Nonconforming Material/Component

Status

Terminated

Product code

NEK

Quantity affected

8884 units

Distribution

Worldwide distribution: USA (nationwide including Puerto Rico) and Internationally to Australia, Brazil, Canada, Chile, Hong Kong, India, Mexico, Netherlands, , New South Wales, Panama, and Paraguay.

Date initiated

2013-05-28

Date posted

2013-06-25

Date terminated

2014-05-13

Location

Memphis, TN