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OFFSET NANO ALTO TOTAL W/INTEGRATED SHOE

Grace Medical, Inc. · Model 607 · UDI-DI 00844505012829

ETAJYJ Prescription
10
510(k) clearances
93
Adverse events
2
Recalls
27
Facilities

Description

OFFSET NANO ALTO TOTAL W/INTEGRATED SHOE - SIZERS INCLUDED TITANIUM/SILICONE

Recalls

DateFirmReason
2013-08-23Medtronic Xomed, Inc.One lot of the product was assembled using the Cam Head version of the same prosthesis instead of the Round head Shaft.
2011-04-27Heinz Kurz GmbH MedizintechnikOuter package labels product .75 mm longer than actual size.

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.