Recall Z-0948-2017 ยท OOD Surgical Film
Tepha Incorporated
GalaSHAPE 3D; product code SH3D03, a medium size oval GalaSHAPE" 3D is indicated for use as a bioresorbable scaffold for soft tissue support and to repair, elevate and reinforce deficiencies where weakness or voids exist that require the addition of material to obtain the desired surgical outcome. This includes reinforcement of soft tissue in plastic and reconstructive surgery, and general soft ti
| Date | Nov 21, 2016 |
| Status | Terminated |
| Reason | Endotoxin values from testing of retains slightly exceeded the established specification. |
| Root cause | Process design |
| Action | Tepha Medical Devices sent a Voluntary Product Recall Notification letter dated November 22, 2016, to all affected customers. Beginning on 11/21/2016, all impacted customers were notified of the recall via phone or in person by Galatea Surgical, a wholly owned subsidiary of Tepha, responsible for the sales and marketing of GalaSHAPE 3D. That notification was followed up by the Tepha recall letter dated November 22, 2016, delivered by certified mail. Customers were instructed to do the following: 1) Immediately review your inventory for the affected lot number listed above. 2) If you do not h |
| Quantity | 29 |
| Distribution | Nationwide Distribution to IN, CA, FL, MI, NV, and MT |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K161092 | GalaSHAPE 3D Tepha, Inc., Aug 23, 2016 |