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Terminated

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

FDA Recall Z-0254-2007 · Posted 2006-12-14

Recalling FirmStryker Biotech
Recall StatusTerminated
Product CodeMQV
Date Initiated2006-08-16
Date Terminated2007-06-20
Product Quantity3314 units

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.

Firm Action

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

Distribution Pattern

Worldwide, including USA, Canada, Sweden, Netherlands, France, Germany, England, Italy, Spain, and Australia.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K041421NAME BONE VOID FILLERStryker Biotech · 2004-08-26

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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