Bacterin International recalls

Bacterin International has 5 recalls on record with the FDA and USDA, the earliest in 2013 and the latest reported on 15 Apr 2015. The most frequent reason is sterility.

Total recalls5since 2013

Last 12 months0reported

Class I00% of total

Ongoing0latest 15 Apr 2015

Recalls per month, last 24 months

click a bar for that month

0Oct '24 0 0 0Jan '25 0 0 0Apr 0 0 0Jul 0 0 0Oct 0 0 0Jan '26 0 0 0Apr 0 0 0Jul 0 0

Severity split

Class I 0 0%Class II 5 100%Class III 0 0%

Why bacterin international is recalled

Product types

By year

2015120%
2014120%
2013360%

All bacterin international recalls, newest first

5 total

Reported	Class	Recall	Company	Reason	Where
15 Apr 2015Device	CLASS II	Instrument Kit for use with OsteoSponge SC grafts recalled	Bacterin International	Sterility	23 states
11 Jun 2014Device	CLASS II	Wound Drain - Label reads in part "Elutia ***Hubless Coated recalled	Bacterin International	Sterility	MT
24 Apr 2013Device	CLASS II	OsteoSelect DBM Putty recalled by Bacterin International	Bacterin International	Other	Nationwide
20 Mar 2013Device	CLASS II	Bacterin Elutia, Hubless Coated Silicone Surgical Wound recalled	Bacterin International	Sterility	Nationwide
20 Feb 2013Device	CLASS II	Osteoselect Demineralized Bone Matrix DMB Putty recalled	Bacterin International	Device Malfunction	Nationwide

About this list

Records come from FDA enforcement reports and USDA FSIS notices, grouped by normalised name. A company operating under several names may appear more than once.