FDA Device

DT Medical -Hintermann Series H3 Poly Inlay, Size 3 5mm Part Number: 300305 components are prostheses for a mobile bearing ankle joint.

Hazard

Incorrect package labeling identifying the device

What You Should Do

Remedy

DT Med Tech LLC initially notified accounts by email notification on 9/25/18 followed by notification letter; The letters explain the process for the identification and return to HealthLink BV (distribution warehouse in The Netherlands) of the products affected (lot AAADP/AAAEM).

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Products

DT Medical -Hintermann Series H3 Poly Inlay, Size 3 5mm Part Number: 300305 components are prostheses for a mobile bearing ankle joint.
Brand
DT MedTech, LLC
UPC
Lot: AAADP

Units Affected

54 units

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