Bacterin International, Inc.

Complete recall history across all FDA and CPSC categories — 5 total recalls

Bacterin International, Inc. appears in recall records across 1 category. This page consolidates all FDA food, drug, and medical device enforcement actions, plus CPSC consumer product recalls associated with this company. Recall data is sourced from openFDA and CPSC public databases.

Device Recalls (5)

FDA medical device enforcement actions by Bacterin International, Inc.

Date Product Reason Class
Mar 9, 2015 Instrument Kit for use with OsteoSponge SC grafts. The Instrument Kit is use... Instrument Kits for OsteoSponge SC grafts, OsteoLock Facet Stabilization Dowe... Class II
May 15, 2014 Wound Drain - Label reads in part "Elutia ***Hubless Coated Silicone Surgical... The recalling firm reported there was inadvertent omission of quarterly (Q4 -... Class II
Feb 21, 2013 OsteoSelect DBM Putty Product Usage: Orthopedic bone filler The firm's retesting procedure was not validated. Class II
Jan 28, 2013 Bacterin Elutia, Hubless Coated Silicone Surgical Wound Drain 24 Fr Round Hub... A portion of a silicone wound drain was found to be cracked. Class II
Apr 18, 2012 Bacterin International, Inc., Osteoselect Demineralized Bone Matrix DMB Putty... Expired product was shipped to two customers. Class II

Frequently Asked Questions

A high number of recalls does not necessarily indicate that a company is unsafe. Large manufacturers that produce thousands of products across multiple categories will statistically appear in recall databases more frequently. What matters more is the severity of each recall (Class I being the most serious), the speed of response, and whether the company proactively identified and addressed the issue. Companies with robust safety programs often catch problems earlier.

Food, drug, and medical device recall data comes from the FDA's openFDA enforcement database, which contains all FDA enforcement reports. Consumer product recall data comes from the U.S. Consumer Product Safety Commission (CPSC). Both sources are public government databases that are updated regularly. RecallCheck aggregates these sources to provide a unified view of a company's recall history.

The FDA classifies recalls into three categories. Class I is the most serious — there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death. Class II means the product may cause temporary or medically reversible health problems, or the probability of serious consequences is remote. Class III is the least serious — the product is unlikely to cause adverse health consequences. CPSC product recalls do not use this classification system.

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