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Karl Storz GmbH & Co. KG · Model 227522 · UDI-DI 04048551279472

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

Description

FISCH Titanium Neomalleus Prosthesis, 1.1 x 5 mm

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.