Z-0948-2017Class II

GalaSHAPE 3D; product code SH3D03, a medium size oval GalaSHAPE" 3D is indicated for use as a bioresorbable...

Name: Z-0948-2017 GalaSHAPE 3D; product code SH3D03, a medium size oval GalaSHAPE" 3D is indicated for use as a bioresorbable...
Creator: Tepha Incorporated
Published: 2016-11-21
License: https://open.fda.gov/license/

Tepha, Incorporated / initiated 2016-11-21 / Terminated / root cause: manufacturing process

FDA source

Tepha Incorporated began a recall of 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... on 2016-11-21. FDA classified it as Class II and gives the reason as "Endotoxin values from testing of retains slightly exceeded the established specification". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0948-2017
Classification: Class II
Status: Terminated
Initiated: 2016-11-21
Posted: 2017-01-05
Terminated: 2017-01-05
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.
Product code: OOD Surgical Film
Reason for recall: Endotoxin values from testing of retains slightly exceeded the established specification.
Root cause tag: manufacturing process
FDA 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 [email protected]. 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 [email protected]. 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
Product codes and lots: Lot Number: 160294

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0948-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0948-2017	Class II	Terminated	Voluntary: Firm initiated	2017-01-11	2017-01-05

Product code OOD

K161092Class IIGalaSHAPE 3DTepha, Inc. / cleared 2016-08-23

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)