Z-0936-2013Class II

Bacterin Elutia, Hubless Coated Silicone Surgical Wound Drain 24 Fr Round Hubless, Full-Fluted Coated with...

Name: Z-0936-2013 Bacterin Elutia, Hubless Coated Silicone Surgical Wound Drain 24 Fr Round Hubless, Full-Fluted Coated with...
Creator: Bacterin International, Inc.
Published: 2013-01-28
License: https://open.fda.gov/license/

Xtant Medical Holdings, Inc. / initiated 2013-01-28 / Terminated / root cause: manufacturing process

FDA source

Bacterin International, Inc. began a recall of Bacterin Elutia, Hubless Coated Silicone Surgical Wound Drain 24 Fr Round Hubless, Full-Fluted Coated with Silver Sulfadiazine STERILE, Box of 10 Part #7118... on 2013-01-28. FDA classified it as Class II and gives the reason as "A portion of a silicone wound drain was found to be cracked". 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-0936-2013
Classification: Class II
Status: Terminated
Initiated: 2013-01-28
Posted: 2013-03-11
Terminated: 2013-07-08
Recalling firm: Xtant Medical Holdings, Inc.
Product: Bacterin Elutia, Hubless Coated Silicone Surgical Wound Drain 24 Fr Round Hubless, Full-Fluted Coated with Silver Sulfadiazine STERILE, Box of 10 Part #7118. Indicated for use in surgical wound drainage.
Product code: OEI Drainage Catheter With Antibiotic
Reason for recall: A portion of a silicone wound drain was found to be cracked.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: Consignees were informed of the recall via e-mail beginning 1/28/13 with a request for a return response. This was followed by a "Voluntary Product Recall Information" letter dated 2/13/13 that described the product issue and provided recommended actions. The firm asked for all product to be returned to them.
Quantity in commerce: 15 boxes (10/box) to 4 consignees in US and 81 boxes (10/box) to 1 foreign consignee
Distribution: 13 US consignees located in CA, CO, MT, TX, UT, and VA. This represents 4 customers and 9 other individual contacts in USA that received marketing samples. Plus 4 Bacterin representives nationwide received samples. Foreign Consingee
Product codes and lots: 005312; 011012; 012111; 012311; 012511; 013011; 019212; 023611; 023811; 024011; 024211; 025912; 033611; 042211

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0936-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0936-2013	Class II	Terminated	Voluntary: Firm initiated	2013-03-20	2013-03-11

Product code OEI

K063245Class IIElutia Coated Closed Surgical Wound DrainBacterin International, Inc. / cleared 2007-11-28

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)