FDA Medical Device Recalls (openFDA)
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
- Recall number
- Z-0254-2007
- Recalling firm
- Stryker Biotech
- Product
- 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
- Status
- Terminated
- Initiated
- 2006-08-16
- Posted
- 2006-12-14
- Terminated
- 2007-06-20
- 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.
- Lot, serial or model codes
- 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
- 510(k) numbers
- ["K041421"]
- PMA numbers
- not on file
- Product code
- MQV
- Firm FEI
- 1000513212
- Firm city
- Hopkinton
- Firm state
- MA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28