Drug recall
Achilles Tendon
FDA recall event 36942 · Class I · Lost Mountain Tissue Bank, Inc.
Key facts
| Event ID | 36942 |
|---|---|
| Recall numbers | B-1095-07, B-1096-07, B-1097-07, B-1098-07, B-1099-07, B-1100-07, B-1101-07, B-1102-07, B-1103-07, B-1104-07, B-1105-07, B-1106-07 and 21 more |
| Recalling firm | Lost Mountain Tissue Bank, Inc. |
| Product type | Biologics |
| Products | Achilles Tendon, Cancellous Bone, Chips (1-4 mm, 30cc), Cancellous Bone, Chips 4-10 mm (15 cc), Cancellous Bone, Chips 4-10 mm (30 cc), Cancellous Bone, Chips (4-10 mm, 60 cc) and 28 more |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Human tissues, recovered from donors without adequate donor eligibility determinations, were distributed. |
| Initiation date | Jul 10, 2006 |
| Termination date | Aug 18, 2009 |
| City | Kennesaw |
| State | GA |
| Country | United States |
| FEI number | 1000512193 |
At a glance
- 10–99 Products in this recall
- 1–9 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports