Recall Z-0948-2017— Tepha Incorporated

Name: FDA recall Z-0948-2017
Creator: U.S. Food and Drug Administration
Published: 2016-11-21

Class II · Terminated

Class II FDA medical device recall by Tepha Incorporated, initiated 2016-11-21, terminated 2017-01-05. It names one FDA 510(k) clearance: K161092. 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.. Reason: Endotoxin values from testing of retains slightly exceeded the established specification..

Recalling firm: Tepha Incorporated
Classification: Class II
Status: Terminated
Initiated: 2016-11-21
Terminated: 2017-01-05
Firm location: Lexington, MA, United States

510(k) clearances named in this recall

1 on FDA's record

K161092 — GalaSHAPE 3DTepha, Inc.·cleared 2016-08-23

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Reason for recall

Endotoxin values from testing of retains slightly exceeded the established specification.

Data sourced from openFDA. This site is unofficial and independent of the FDA.