Bacterin International, Inc.: Medical Device Recall in 2013 - (Recall #: Z-0936-2013)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2013.

Data Source: FDA.

Product Description:

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 Classification:

Class II

Date Initiated: January 28, 2013

Date Posted: March 20, 2013

Recall Number: Z-0936-2013

Event ID: 64326

Reason for Recall:

A portion of a silicone wound drain was found to be cracked.

Status: Terminated

Product Quantity: 15 boxes (10/box) to 4 consignees in US and 81 boxes (10/box) to 1 foreign consignee

Code Information:

005312; 011012; 012111; 012311; 012511; 013011; 019212; 023611; 023811; 024011; 024211; 025912; 033611; 042211

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated