FIDJI (2016-09-27)

Starting date:

September 27, 2016

Posting date:

November 15, 2016

Type of communication:

Medical Device Recall

Subcategory:

Medical Device

Hazard classification:

Type II

Source of recall:

Health Canada

Issue:

Medical Devices

Audience:

General Public, Healthcare Professionals, Hospitals

Identification number:

RA-61018

• Reason
• Affected products

Affected Products

1. FIDJI LUMBAR REAMER
2. FIDJI LUMBAR DISTRACTOR
3. FIDJI LUMBAR INITIAL DISTRACTOR
4. FIDJI LUMBAR  CURETTE
5. FIDJI LUMBAR RETRACTOR
6. FIDJI LUMBAR SLIDING MALLET
7. FIDJI LUMBAR IMPACTOR SHAFT
8. FIDJI LUMBAR GRAFT TAMPER
9. FIDJI LUMBAR CAGES JIG
10. FIDJI LUMBAR FINAL IMPACTOR
11. FIDJI LUMBAR EXTRACTION BLOCKER
12. FIDJI  CERVICAL GRAFT TAMPER
13. FIDJI  CERVICAL CAGE JIG
14. FIDJI  CERVICAL FINAL IMPACTOR
15. FIDJI CERVICAL IMPACTOR
16. FIDJI  CERVICAL DECLIPPING DEVICE
17. FIDJI  CERVICAL DEPTH GAUGE
18. FIDJI  CERVICAL TRIAL HOLDER
19. FIDJI  CERVICAL TRIAL CAGE HOLDER
20. FIDJI  CERVICAL CURETTE
21. FIDJI  CERVICAL FIN REMOVER

Reason

Instructions cleaned, disinfected, under REV 1 instructions for use (IFU) for the Java Posterior Stabilization, Wallis Posterior Dynamic Stabilization and FIDJI cervical and lumbar cage systems may not be adequately cleaned and decontaminated resulting in a risk of infection.

Affected products