Recalls / —

—#202700

Product

Magnifuse Bone Graft, Large, Size: 14mm x 25mm, REF 7509014, Human Tissue, Demineralized Bone Matrix, sterile.

FDA product code

MQV — Filler, Bone Void, Calcium Compound

Device class

Class 2

Medical specialty

Orthopedic

510(k) numbers

K082615

Affected lot / code info

Serial numbers: A57958-011, A57958-012, A57958-013, A57958-014, A57958-015, A57958-016, A57958-017, A57958-018, A57958-019, A57958-020, A57958-021, A57958-022, A57958-023, A57958-024, A57958-025, A57958-026, A57958-027, A57958-028, A57958-029, A57958-030, A57958-031, A57958-033, A57958-034, A57958-035, A57958-036, A57958-037, A57958-038, A57958-048, A57958-050, A57958-051, A57958-052, A57958-053, A57958-054, A57958-055, A57958-056, A57958-057, A57958-058, A57958-059, A57958-060, A57958-066, A57958-069, A57958-070, A57958-072, A57958-073, A57958-074, A57958-075, A57958-076, A57958-077, A57958-078, A57958-079, A57958-080, A57958-081, A57958-082, A57958-085, A57958- 086. Exp. 2/15/2025. UDI-DI 00613994986467

Why it was recalled

The incorrect product labeling was applied to the product indicating the wrong size of product.

Root cause (FDA determination)

Process control

Action the firm took

Beginning 7/31/2023, In the U.S. Medtronic initiated a Consignee Notification and Customer Confirmation Form via UPS 2-Day delivery to each listed consignee. Consignees were asked to quarantine and return any affected unused product they may have and complete and return the Customer Confirmation Form (i.e. reply form). Additionally, consignees were asked to forward this notification to those who need to be aware within the organization or to any location which the devices have been transferred.

Recalling firm

Firm

Medtronic Sofamor Danek USA Inc

Address

1800 Pyramid Pl, Memphis, Tennessee 38132-1703

Distribution

Distribution pattern

US Nationwide distribution in the states of ID, IN, MN, NC, NY, OH, OR, WA, and WI.

Timeline

Recall initiated

2023-07-31

Posted by FDA

2023-09-08

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #202700. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.