Calstrux (Previously known as TCP Putty)- Absorbable Bone Void Filler, packaged in: Catalog Number: 400-05: quantity-5cc
FDA device recall Z-0254-2007 · posted 2006-12-14 · Terminated
Recall details
- Recalling firm
- Stryker Biotech
- Reason for recall
- 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.
- Action taken
- On 8/25/06 Stryker notified consignees of the recall by letter and attached a new, revised package insert inside the mailing envelope
- Root cause
- Other
- Status
- Terminated
- Product code
- MQV
- Quantity affected
- 3314 units
- Distribution
- Worldwide, including USA, Canada, Sweden, Netherlands, France, Germany, England, Italy, Spain, and Australia.
- Date initiated
- 2006-08-16
- Date posted
- 2006-12-14
- Date terminated
- 2007-06-20
- Location
- Hopkinton, MA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| NAME BONE VOID FILLER (K041421) | Stryker Biotech | 2004-08-26 |