Z-0948-2017 Class II Terminated
FDA device recall Z-0948-2017 was initiated by Tepha Incorporated on November 21, 2016 and is designated Class II. Reason for recall: Endotoxin values from testing of retains slightly exceeded the established specification. The recall status is terminated (terminated January 5, 2017). Affected quantity: 29.
Recall Details
- Product Type
- Devices
- Report Date
- January 11, 2017
- Initiation Date
- November 21, 2016
- Termination Date
- January 5, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 29
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.
Distribution Pattern
Nationwide Distribution to IN, CA, FL, MI, NV, and MT
Code Information
Lot Number: 160294