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
This recall has been terminated (originally issued December 14, 2006).
- Company
- Stryker Biotech
- Recall Initiated
- August 16, 2006
- Posted
- December 14, 2006
- Terminated
- June 20, 2007
- Recall Number
- Z-0254-2007
- Quantity
- 3314 units
- Firm Location
- Hopkinton, MA
- Official Source
- View on FDA website ↗
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.
Distribution
Worldwide, including USA, Canada, Sweden, Netherlands, France, Germany, England, Italy, Spain, and Australia.
Lot / Code Info
Lot Numbers: 5cc: TUAN003, TUAN007, TUBN012, TUBN013, TUCN018, TUEN023, TUEN024. 10cc: TUAN002, TUAN004, TUAN006, TUBN01. 15cc: TU06026, TUAN001, TUAN005, TUAN008, TUBN009, TUBN015, TUBN016, TUCN019, TUCN020, TUDN021, TUDN022, TUEN025
Root Cause
Other
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