Product description
The Albatros plates are manufactured at the facilities of SARL CHOC, rue Louis Lépine, Albasud 3, 82000 Montauban, France.
They are manufactured from ISO 5832-2 standard T40 titanium. All materials are obtained from ISO 9001 certified suppliers, who provide for each titanium delivery a material conformity certificate with a physicochemical analysis.
The plates are produced in accordance with our manufacturing procedures: a manufacturing order is issued by the Production Manager. For each manufacturing order, the Production Manager assigns a four digit batch number. The manufacturing order details all the operations to be carried out on the products. At each stage, various dimensional verifications are carried out by the manufacturing operators and by the Production Manager. All inspection forms are kept with the manufacturing order.
All Albatros plates are 1.6mm thick.
Dimensional characteristics
Right-hand & left-hand Albatros BMA plates with a 2, 3, 4, 5 or 6mm wide shim.
Product Reference: 38.02.02R / 38.02.02L - 38.02.03R / 38.02.03L - 38.02.04R / 38.02.04L - 38.02.05R / 38.02.05L - 38.02.06R / 38.02.06L.
Albatros plates are used in the following cases:
- Basal metatarsal addition
- Midfoot arthrodesis (M1/C1 Lapidus)
- Phalanx metatarsal arthrodesis
Each plate is fixed using Albatros screws (cortical or cancellous, depending on the surgeon's choice) which are locked in the plate.
To ensure traceability, the plates are individually packaged individually in double blister packs, the first containing the plate and a sterilisation indicator label; the second blister contains the first blister and five traceability stickers with the product reference, description and batch number.
The packed plates are then sent to ISOTRON France (MIN des Arnavaux- 13014 MARSEILLE) for sterilisation by gamma radiation according to the ISO 11137-02, ISO 11737-1, ISO 11737-2, EN 552, EN 556 standards and dose mapping. After sterilisation, ISOTRON returns the batch of sterilised plates with a certificate of sterilisation by gamma radiation.
The products in the packaging are then labelled. The label includes the description, the reference, the production batch number, the method of sterilisation, the expiry date, the "single use" and "read instructions before use" symbols, the manufacturer's name and address and the CE 1014 markings.
The plates are packed in boxes identically labelled as above, stretch-wrapped and stored in closed cupboards, away from direct light and humidity.
Storage conditions: no special conditions.
