Documenten - Waarschuwingen van fabrikanten medische hulpmiddelen

1. Smith & Nephew Inc, FSN-R-2020-04, R3 Acetabular Shells

    Smith+Nephew voert een vrijwillige terugroepactie uit van specifieke batches van de R3 Acetabular Shells, vanwege een ...

   Waarschuwing | 28-04-2020

2. Stryker RA2020-2209440 Restoration ®Anatomic Shell

   Stryker has discovered that the Restoration Anatomic Shell (RAS) implants, sizes 54mm – 68mm (Left and Right), may fall off its ...

   Waarschuwing | 22-04-2020

3. Stryker Spine - Leesburg RA2020-2366861 NileTM Alternative Fixation Spinal System Band

   Stryker has identified that the expiration date of 2028-11-26, printed on patient (DO) labels and the secondary packaging label ...

   Waarschuwing | 17-04-2020

4. Stryker Spine - Leesburg RA2020-2362278 Aleutian® AN (Anatomically Narrow) Lordotic Spreaders

   Stryker’s Spine division received reports of intra-operative disassociation of the spreader tip from its shaft for the Aleutian ...

   Waarschuwing | 17-04-2020

5. Valoc AG FSN1 FSCA1 Adapter Optiloc for handpiece, length 26mm

   De adapter Optiloc® werkt mogelijk niet goed in het vergrendelingsmechanisme van het handstuk. Dit kan resulteren in een gebrek ...

   Waarschuwing | 07-04-2020

6. Zimmer Biomet ZFA 2020-00012 - Comprehensive Reverse Shoulder System

   Biomet Orthopedics is conducting a medical device field safety corrective action (removal) for onesingle lot of the Comprehensive ...

   Waarschuwing | 31-03-2020

7. 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

8. Biomet UK Ltd ZFA 2020-00040 - Biolox® Delta Modular Ceramic Heads

   A product complaint investigation revealed that the above batches may contain items of which the neck length on the product label ...

   Waarschuwing | 11-03-2020

9. Zimmer Biomet ZFA 2020-00026 - StageOne (Select) Bone Cement Spacer Molds

   As a precautionary measure Zimmer Orthopedics is conducting a medical device Field Safety Corrective Action (removal) for ...

   Waarschuwing | 10-03-2020

10. Zimmer Biomet ZFA 2019-00433 - Innex Anchorage Stems

    As a precautionary measure Zimmer GmbH is conducting a medical device Field Safety Corrective Action (Removal) for specific lots ...

    Waarschuwing | 18-02-2020