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Total Middle Ear Implant
Spiggle & Theis Medizintechnik GmbH · Model 11955 · UDI-DI 04250381804261
ETA
Prescription
1
510(k) clearances
93
Adverse events
2
Recalls
27
Facilities
Description
Total middle ear implant, fixed size, titanium round-centric head, 5.5x0.3 mm, sterile
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2013-08-23 | Medtronic Xomed, Inc. | One lot of the product was assembled using the Cam Head version of the same prosthesis instead of the Round head Shaft. |
| 2011-04-27 | Heinz Kurz GmbH Medizintechnik | Outer package labels product .75 mm longer than actual size. |
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