Documenten - Waarschuwingen van fabrikanten medische hulpmiddelen

1. Smith & Nephew R-2020-03 - Footprint Ultra PK Suture Anchor

   Met deze brief willen wij u informeren dat Smith & Nephew, Inc. vrijwillig specifieke partijen van de Footprint Ultra PK Suture ...

   Waarschuwing | 20-03-2020

2. Arthrex, R524_NL, Low Profile Screw, Ti, 6.7 mm x 65.0 mm, Cannulat

   De schroeven in het pakket zijn 5 mm korter dan de bedoeling is.

   Waarschuwing | 10-07-2020

3. Smith & Nephew, Inc, Endoscopy Division, FSN-R-2020-11, SUTUREFIX ULTRA 1.7MM DRILL (S)

   Door middel van deze brief delen wij u mede dat Smith & Nephew, Inc. een vrijwillige terugroeping uitvoert van een partij ...

   Waarschuwing | 29-06-2020

4. Acumed R21-006 - T15 Stick Fit Hexalobe Drivers

   It has come to Acumed’s attention that two batches of T15 Stick Fit Hexalobe Drivers have features out of specification. The ...

   Waarschuwing | 21-12-2021

5. Medtronic Sofamor Danek USA, Inc., FSN-FA973, Break-off set screw

   Medtronic is voluntarily recalling two lots of the Braive™ Break off Set Screw that are impacted by a thread profile defect due ...

   Waarschuwing | 30-04-2021

6. MEDARTIS AG FSCA-2020-001 - MODUS and MODUS 2 Pliers

   The previous information contained in the IFU was not specific enough for the following pliers: - M2-2016 2.0-2.5 Three-Point ...

   Waarschuwing | 17-12-2020

7. Safe Orthopaedics, FSN-22-03, CEMENT PUSHER KIT

   Safe Orthopedics has detected an anomaly concerning the instructions for use of the Cement Pushers and Kit Needle kits. The ...

   Waarschuwing | 28-12-2022

8. Stryker Joint Replacement, RA2023-3471895, Scorpio, Duracon, PCA, Trident

   The industry guidance for storage duration of Ultra High Molecular Weight Polyethylene (UHMWPE) raw material used in the ...

   Waarschuwing | 19-12-2023

9. KARL STORZ SE & Co. KG-23-0015, BEYER Antrum Punch, Antrum Punch, Sphenoid Punch, Sphenoid Punch, Sphenoid Punch, Galea Spring Hook, Uvula Retractor, Optical Biopsy and Grasping Forceps, Grasping Forceps, Optical Scissor, Working Insert with steering lever

   It was found that there is not insufficient evidence to show that the reprocessing method of the products was adequately ...

   Waarschuwing | 04-01-2024

10. SYNTHES GMBH, FSN-2050712, Universal Chuck

    Dit product wordt teruggeroepen vanwege een mogelijk probleem met het ontwerp van de bovenkap van de klauwkop. De bovenste kap ...

    Waarschuwing | 31-12-2021