Stryker Biotech
Hopkinton, MA, US
Stryker Biotech appears in FDA device records in Hopkinton, MA. FDA records list one 510(k) clearance, no PMA records and no registered establishments. As of , FDA records show 3 recalls for this company.
FDA records held for this company
510(k) clearance history
FDA records hold 1 510(k) clearance for Stryker Biotech in 2004.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2004 | 1 |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-1727-2011 | Stryker Biotech OP-1 Putty (OP-1, BMP-7, bone morphogenetic protein) "Catalog numbers: 300-50, 300-55 OP-1 Putty is authorized by Federal law for use as an alternative to autograft in compromised patients requiring revision posterolateral (intertransverse) lumbar spinal fusion, for whom autologous bone and bone marrow harvest are not feasible or are not expected to promote fusion. Examples of compromising factors include osteoporosis, smoking and diabetes. | A change to the Preparation for Use section was identified where 2.5cc was replaced with 2cc-3cc volume and was not approved | Terminated | ||
| Z-2311-2008 | Stryker Biotech OP- 1 Implant is indicated for use as an alternative to autograft in recalcitrant long bone nonunions where use of autograft is unfeasible and alternative treatments have failed. Catalog Number: 100-25 | Product Package Insert misprint-text offset | Terminated | ||
| Z-0254-2007 | 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 | 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. | Terminated |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain