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Health product recall

Synthes (Canada) Ltd. Products

Starting date:
November 7, 2012
Posting date:
December 10, 2012
Type of communication:
Medical Device Recall
Subcategory:
Medical Device
Hazard classification:
Type II
Source of recall:
Health Canada
Issue:
Medical Devices
Audience:
General Public (GP), Healthcare Professionals, Hospitals
Identification number:
RA-16337

Recalled Products

  1. Tit.Dist.Rem.NL
  2. Tit.Dist.Fem.Solid.Nail
  3. Ti.Dist.Fem.Cann.Nail
  4. Ti.Unream.Fem.Nail
  5. Titanium Cannulated Cannulated Femoral Nail
  6. Titanium Humeral Nail
  7. Unreamed Tibial Nail Sterile
  8. Titanium Cannulated Tibial Nail
  9. Ti.Cannulated Retrograde / Antegrade Femoral Nail System, Sterile
  10. Tibial Nail System Ex-Ti Cannulated Tibial Nail, Sterile
  11. Ti Cannulated Humeral Nail System Sterile
  12. Ti Cannulated Lateral Entry Femoral Nail, Sterile
  13. Hindfoot Arthrodesis Nail System - Nail (Sterile)
  14. Ti Adolescent Lateral Entry Femoral Nail System - Femoral Nails, Sterile

Reason

Synthes is recalling all lots of the Synthes Trauma Nailing systems. This is due to the possibility that the outer pouch of the packaging may be compromised.

Affected products

A. Tit.Dist.Rem.NL

Lot or serial number

All Lots

Model or catalog number

More than 10 numbers, contact manufacturer

Companies
Manufacturer
Synthes (Canada) Ltd.

B. Tit.Dist.Fem.Solid.Nail

Lot or serial number

All Lots

Model or catalog number

More than 10 numbers, contact manufacturer

Companies
Manufacturer
Synthes (Canada) Ltd.

C. Ti.Dist.Fem.Cann.Nail

Lot or serial number

All Lots

Model or catalog number

More than 10 numbers, contact manufacturer

Companies
Manufacturer
Synthes (Canada) Ltd.

D. Ti.Unream.Fem.Nail

Lot or serial number

All Lots

Model or catalog number

More than 10 numbers, contact manufacturer

Companies
Manufacturer
Synthes (Canada) Ltd.

E. Titanium Cannulated Femoral Nail

Lot or serial number

All Lots

Model or catalog number

More than 10 numbers, contact manufacturer

Companies
Manufacturer
Synthes (Canada) Ltd.

F. Titanium Humeral Nail

Lot or serial number

All Lots

Model or catalog number

More than 10 numbers, contact manufacturer

Companies
Manufacturer
Synthes (Canada) Ltd.

G. Unreamed Tibial Nail Sterile

Lot or serial number

All Lots

Model or catalog number

More than 10 numbers, contact manufacturer

Companies
Manufacturer
Synthes (Canada) Ltd.

H. Titanium Cannulated Tibial Nail

Lot or serial number

All Lots

Model or catalog number

More than 10 numbers, contact manufacturer

Companies
Manufacturer
Synthes (Canada) Ltd.

I . Ti.Cannulated Retrograde / Antegrade Femoral Nail System, Sterile

Lot or serial number

All Lots

Model or catalog number

More than 10 numbers, contact manufacturer

Companies
Manufacturer
Synthes (Canada) Ltd.

J. Tibial Nail System Ex-Ti Cannulated Tibial Nail, Sterile

Lot or serial number

All Lots

Model or catalog number

More than 10 numbers, contact manufacturer

Companies
Manufacturer
Synthes (Canada) Ltd.

K. Ti Cannulated Humeral Nail System Sterile

Lot or serial number

All Lots

Model or catalog number

More than 10 numbers, contact manufacturer

Companies
Manufacturer
Synthes (Canada) Ltd.

L. Ti Cannulated Lateral Entry Femoral Nail, Sterile

Lot or serial number

All Lots

Model or catalog number

More than 10 numbers, contact manufacturer

Companies
Manufacturer
Synthes (Canada) Ltd.

M. Hindfoot Arthrodesis Nail System - Nail (Sterile)

Lot or serial number

All Lots

Model or catalog number

More than 10 numbers, contact manufacturer

Companies
Manufacturer
Synthes (Canada) Ltd.

N. Ti Adolescent Lateral Entry Femoral Nail System - Femoral Nails, Sterile

Lot or serial number

All Lots

Model or catalog number

More than 10 numbers, contact manufacturer

Companies
Manufacturer
Synthes (Canada) Ltd.