Recall Z-0684-2016 ยท FFO Retractor, Self-Retaining
Abeon Medical Corporation
TLC Self Retaining Retractor System Contents 1-RETRACTOR FRAME 6-ELASTIC STAYS STERILE EO Rx ONLY. Indicated for use in the retraction of soft tissue away from the operative surface.
| Date | Nov 25, 2015 |
| Status | Terminated |
| Reason | The firm was notified by some of their customers that some of the sealed pouches contain tears compromising the sterility of the product. |
| Root cause | Packaging |
| Action | On 12/17/2015 the firm sent Recall Notification Letters to their customers. The letter identified the product, problem, and actions to be taken by the customer. |
| Quantity | 2,570 units |
| Distribution | Worldwide Distribution-US (nationwide) including the states of AL, AR, AZ, CA, CT,FL, GA, IA, IN, KS, KY, MA, MD, MI, MN, NC, NH, NJ, OH, SC, TN, TX, UT, VA & WI., and the countries of Austria, Germany, Italy, Japan, Spain, Sweden & Switzerland. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.