Class 2 Device Recall GalaSHAPE 3D

• Date Initiated by Firm: November 21, 2016
• Create Date: January 05, 2017
• Recall Status: Terminated on January 05, 2017
• Recall Number: Z-0948-2017
• Recall Event ID: 75827
• 510(K)Number: K161092
• Product Classification: surgical film - Product Code OOD
• Product: 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 tissue reconstruction. GalaSHAPE" 3D is also indicated for the repair of fascial defects that require the addition of a reinforcing or bridging material to obtain the desired surgical result.
• Code Information: Lot Number: 160294
• Recalling Firm/ Manufacturer: Tepha Incorporated; 99 Hayden Ave Ste 360; Lexington MA 02421-7966
• For Additional Information Contact: 781-357-1750
• Manufacturer Reason for Recall: Endotoxin values from testing of retains slightly exceeded the established specification.
• FDA Determined 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 have any of the affected lot in your inventory, complete the enclosed Recall Acknowledgment Form, indicate that you have zero (O) inventory and fax the completed form back to (781) 357-1701 or email it to contact@galateasurgical.com. 3) If you do have inventory from the affected lot, please complete the enclosed Recall Acknowledgement Form and fax back to Tepha, Inc. at (781) 357-1701 or email it to contact@galateasurgical.com. A Galatea representative will contact you to arrange for the product return. If you have any questions or require assistance with the return of the recalled product, please call Galatea Surgical, at (781) 357-1752. For questions regarding this recall call 781-357-1750.
• Quantity in Commerce: 29
• Distribution: Nationwide Distribution to IN, CA, FL, MI, NV, and MT
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = OOD and Original Applicant = Tepha, Inc.