Osteotech Inc
Complete recall history across all FDA and CPSC categories — 12 total recalls
Osteotech 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 (12)
FDA medical device enforcement actions by Osteotech Inc
| Date | Product | Reason | Class |
|---|---|---|---|
| Apr 20, 2012 | Grafton DBM Orthoblend Small Defect Multiple Sizes Grafton is a human bon... | Multiple lots of GRAFTON ¿ and XPANSE ¿, which are used for bone grafting pr... | Class II |
| Apr 20, 2012 | Grafton DBM A-Flex Multiple Sizes Grafton is a human bone allograft produ... | Multiple lots of GRAFTON ¿ and XPANSE ¿, which are used for bone grafting pr... | Class II |
| Apr 20, 2012 | Optimum Expanse R Grafton is a human bone allograft product containing dem... | Multiple lots of GRAFTON ¿ and XPANSE ¿, which are used for bone grafting pr... | Class II |
| Apr 20, 2012 | Grafton DBM Gel Multiple Sizes Grafton is a human bone allograft product ... | Multiple lots of GRAFTON ¿ and XPANSE ¿, which are used for bone grafting pr... | Class II |
| Apr 20, 2012 | Grafton DBM Flex Multiple Sizes Grafton is a human bone allograft product... | Multiple lots of GRAFTON ¿ and XPANSE ¿, which are used for bone grafting pr... | Class II |
| Apr 20, 2012 | Optimum Expanse S Multiple sizes Grafton is a human bone allograft produc... | Multiple lots of GRAFTON ¿ and XPANSE ¿, which are used for bone grafting pr... | Class II |
| Apr 20, 2012 | Grafton DBM Orthoblend Large Defect Multiple Sizes Grafton is a human bo... | Multiple lots of GRAFTON ¿ and XPANSE ¿, which are used for bone grafting pr... | Class II |
| Apr 20, 2012 | Grafton DBM Matrix PLF Multiple Sizes Grafton is a human bone allograft p... | Multiple lots of GRAFTON ¿ and XPANSE ¿, which are used for bone grafting pr... | Class II |
| Apr 20, 2012 | Grafton DBM Crunch Multiple Sizes Grafton is a human bone allograft produ... | Multiple lots of GRAFTON ¿ and XPANSE ¿, which are used for bone grafting pr... | Class II |
| Apr 20, 2012 | Grafton DBM Matrix Strips Multiple Sizes Grafton is a human bone allograf... | Multiple lots of GRAFTON ¿ and XPANSE ¿, which are used for bone grafting pr... | Class II |
| Apr 20, 2012 | Grafton DBM Putty Multiple Sizes Grafton is a human bone allograft produc... | Multiple lots of GRAFTON ¿ and XPANSE ¿, which are used for bone grafting pr... | Class II |
| Apr 20, 2012 | Grafton DBM Orthoblend Large Defect Multiple Sizes Grafton is a human bo... | Multiple lots of GRAFTON ¿ and XPANSE ¿, which are used for bone grafting pr... | 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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