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Osseointegration Prosthetic Limb
OSSEOINTEGRATION INTERNATIONAL PTY LTD · Model M10 Grub Screw Tibial Connector · UDI-DI 19356371001008
IQO
Prescription
0
510(k) clearances
48
Adverse events
2
Recalls
47
Facilities
Description
Tibial Connector Assembly - M10
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2012-07-27 | Biomet U.K., Ltd. | A drafting error during an unrelated design change has led to 4 misleading dimensions on the drawing. The CAD model remained the same thickness but the problem dimensions were acci |
| 2007-09-11 | Stryker Howmedica Osteonics Corp. | The bubble in a vial of the Pelvic Alignment Level (PAL) was wider than the level marking. Upon opening the PAL and removing the vial, it was discovered that the vial was leaking |
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