Recalls / —
—#127361
Product
Accell Evo3C Demineralized Bone Matrix, 5 cc, Model Number: 02-6000-050 , Lot Number: 132160. Product Usage: Accell Evo3c Demineralized Bone Matrix Putty is intended for filling voids and gaps in the skeletal system that are not intrinsic to the stability of the bony structure. Accell Evo3c is indicated for use as a bone graft extender in the spine, extremities and pelvis, or as a bone void filler in the extremities and pelvis. The voids or gaps may be surgically created defects or the result of traumatic injury to the bone.
- FDA product code
- MBP — Filler, Bone Void, Osteoinduction (W/O Human Growth Factor)
- Device class
- Class 2
- Medical specialty
- Orthopedic
- 510(k) numbers
- K091193
- Affected lot / code info
- Model Number: 02-6000-050 , Lot Number: 132160.
Why it was recalled
This lot of Accell Evo3C Demineralized Bone Matrix, 5cc was incorrectly packaged in boxes that describe the product as Accell Evo3 Demineralized Bone Matrix. Evo3C is contraindicated for treatment of vertebral compression and not indicated for use in the posterolateral spine.
Root cause (FDA determination)
Packaging
Action the firm took
Integra sent an Urgent Voluntary Medical Device Recall dated May 19, 2014 to customers via mail (traceable courier service). The recall notification letter identified affected product, reason for recall and actions to be taken Customers were instructed to complete the "RECALL ACKNOWLEDGEMENT AND RETURN FORM". and return to: FCA1@integralife.com or FAX to 1-609-275-9445. For questions contact Customer Service at 1-800-550-7155.
Recalling firm
- Firm
- Integra LifeSciences Corp.
- Address
- 311 Enterprise Dr, Plainsboro, New Jersey 08536-3344
Distribution
- Distribution pattern
- US Nationwide Distribution
Timeline
- Recall initiated
- 2014-05-19
- Posted by FDA
- 2014-06-25
- Terminated
- 2014-09-05
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #127361. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.