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 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.

Recall number

Z-0948-2017

Recalling firm

Tepha Incorporated

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.

Status

Terminated

Initiated

2016-11-21

Posted

not on file

Terminated

2017-01-05

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 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

29

Distribution

Nationwide Distribution to IN, CA, FL, MI, NV, and MT

Lot, serial or model codes

Lot Number: 160294

510(k) numbers

["K161092"]

PMA numbers

not on file

Product code

OOD

Firm FEI

3005670760

Firm city

Lexington

Firm state

MA

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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