—#118498

Product

INFUSE(R) Bone Graft, MEDIUM KIT, REF 7510400, Medtronic Sofamore Danek USA, Inc., 1800 Pyramid Place, Memphis, Tennessee 38132 orthopaedic

FDA product code: NEK — Filler, Recombinant Human Bone Morphogenetic Protein, Collagen Scaffold With Metal Prosthesis, Osteoinduction
Device class: Class 3
Medical specialty: Unknown
PMA numbers: P000058
Affected lot / code info: Lots: M111063AAA, M111063AAB, M111064AAI, M111064AAF, M111064AAE, 111064AAT, M111064AAU, M111064AAX, M111064AAJ, M111064AAR, M111064AAS

Why it was recalled

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

Root cause (FDA determination)

Nonconforming Material/Component

Action the firm took

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.

Recalling firm

Firm: Medtronic Sofamor Danek USA Inc
Address: 1800 Pyramid Place, Memphis, Tennessee 38132

Distribution

Distribution pattern: 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.

Timeline

Recall initiated: 2013-05-28
Posted by FDA: 2013-06-25
Terminated: 2014-05-13
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #118498. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.