Home / Recalls / Bacterin International, Inc. / Z-0936-2013

Z-0936-2013 Class II Terminated

Recalled by Bacterin International, Inc. — Belgrade, MT

Recall Details

Product Type
Devices
Report Date
March 20, 2013
Initiation Date
January 28, 2013
Termination Date
July 8, 2013
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
15 boxes (10/box) to 4 consignees in US and 81 boxes (10/box) to 1 foreign consignee

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.

Reason for Recall

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

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

Code Information

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

Other recalls by Bacterin International, Inc.

  • Z-1396-2015 Class II — Instrument Kit for use with OsteoSponge SC grafts. The Instrument Kit is used t (March 9, 2015)
  • Z-1680-2014 Class II — Wound Drain - Label reads in part "Elutia ***Hubless Coated Silicone Surgical Wo (May 15, 2014)
  • Z-1138-2013 Class II — OsteoSelect DBM Putty Product Usage: Orthopedic bone filler (February 21, 2013)
  • Z-0800-2013 Class II — Bacterin International, Inc., Osteoselect Demineralized Bone Matrix DMB Putty; (April 18, 2012)