3 results
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14ms
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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TC-PLUS Solution Femoral Component Size 12L, part 21041-C, lot 0006.13.2635.
FDA Recall
Terminated
·Plus Orthopedics·Product code JWH·September 9, 2002
Cook brand Zenith AAA Bifurcated main body graft with the H&L-B One-Shot Introducer System, preloaded bifurcated main body graft - aortic graft diameter 24 mm - iliac leg diameters 11 mm - main body lengths contralateral limb 88mm ipsilateral limb 133 mm - delivery system 18 FR;Catalog no. TFB-24-88.
FDA Recall
Terminated
·Cook, Inc.·Product code MIH·June 10, 2004
The Acumed Tension Band Pin is a fixation pin which is .0625" in diameter and is available in lengths between 35mm and 90mm. It is to be used in conjunction with commonly used orthopedic wire. 50.0 mm Tension Band Pin; Part Number 30-0097 70.0 mm Tension Band Pin; Part Number 30-0098 90.0 mm Tension Band Pin; Part Number 30-0099 50.0 mm Tension Band Kit; Part Number TB-1550K-S 70.0 mm Tension Band Kit; Part Number TB-1570K-S 90.0 mm Tension Band Kit; Part Number TB-1590K-S Product Usage: Acumed Tension Band Pin is intended to be used with orthopedic wire to address malleolar, patella, and olecranon fractures in tension band wiring procedures. This device is not intended for usage in the spine.
FDA Enforcement
Class II
·Terminated·Acumed LLC·May 7, 2014