Recall Z-0254-2007 ยท MQV Filler, Bone Void, Calcium Compound
Stryker Biotech
Calstrux (Previously known as TCP Putty)- Absorbable Bone Void Filler, packaged in: Catalog Number: 400-05: quantity-5cc Catalog Number: 400-10: quantity 10cc Catalog Number: 400-15: quantity 15cc
| Date | Dec 14, 2006 (initiated Aug 16, 2006) |
| Status | Terminated |
| Reason | Lack of Labeling Precautions. Calstrux should not be used in combination with other products and the volume used should approximate the size of the defect. Adverse reactions have been reported with over filling the defect site or combination product usage, including localized induration, swelling, inflammation, wound drainage, infection and device migration. |
| Root cause | Other |
| Action | On 8/25/06 Stryker notified consignees of the recall by letter and attached a new, revised package insert inside the mailing envelope |
| Quantity | 3314 units |
| Distribution | Worldwide, including USA, Canada, Sweden, Netherlands, France, Germany, England, Italy, Spain, and Australia. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K041421 | NAME BONE VOID FILLER Stryker Biotech, Aug 26, 2004 |