Accell Evo3C Demineralized Bone Matrix, 5 cc, Model Number: 02-6000-050 , Lot Number: 132160. Product Usage: Accell Evo3
FDA device recall Z-1868-2014 · posted 2014-06-25 · Terminated
Recall details
- Recalling firm
- Integra LifeSciences Corp.
- Reason for recall
- 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.
- Action taken
- 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.
- Root cause
- Packaging
- Status
- Terminated
- Product code
- MBP
- Quantity affected
- 61
- Distribution
- US Nationwide Distribution
- Date initiated
- 2014-05-19
- Date posted
- 2014-06-25
- Date terminated
- 2014-09-05
- Location
- Plainsboro, NJ
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ACCELL EVO3C (K091193) | Isotis Orthobiologics, Inc. | 2009-08-10 |