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Health product recall

RIA Systems

Starting date:
October 11, 2012
Posting date:
October 29, 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-15171

Recalled Products:

  1. RIA System - Tube Assembly
  2. RIASystem - Drive Shaft Seal
  3. RIA System - Reamer Head, Sterile
  4. RIA System - Locking Clip
  5. RIA System - Graft Filter with Plunger

Reason

Synthes (Canada), Ltd. Received information from their supplier, Synthes (USA) LLC, that the indications on the current version of the Reamer Irrigator/Aspirator (RIA) package insert and Technique Guide differ from the indications approved by Health Canada on Licence number 22443.

Affected products

A. RIA System - Tube Assembly

Lot or serial number

More than 10 numbers, contact manufacturer

Model or catalog number
  • 314.745S
  • 314.746S
Companies
Manufacturer
Synthes (Canada) Ltd.

B. RIA System - Drive Shaft Seal

Lot or serial number

More than 10 numbers, contact manufacturer

Model or catalog number
  • 351.718S
Companies
Manufacturer
Synthes (Canada) Ltd.

C. RIA System - Reamer Head, Sterile

Lot or serial number

More than 10 numbers, contact manufacturer

Model or catalog number
  • 352.250S
  • 352.251S
  • 352.252S
  • 352.253S
  • 352.254S
  • 352.255S
  • 352.256S
  • 352.257S
Companies
Manufacturer
Synthes(Canada) Ltd.

D. RIA System - Locking Clip

Lot or serial number
  • 6793495
  • 6817492
  • 6840162
  • 6840166
  • 6856180
  • 6878365
  • 6905770
  • 6926275
  • 6931109
Model or catalog number
  • 352.260S
Companies
Manufacturer
Synthes(Canada) Ltd.

E. RIA System - Graft Filter with Plunger

Lot or serial number
  • 6878341
  • 6878361
Model or catalog number
  • 352.229S
Companies
Manufacturer
Synthes(Canada) Ltd.

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