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Toothed Rack Retractor for Matrix and Removal Tool for T-PAL (2013-10-25)
- Starting date:
- October 25, 2013
- Posting date:
- December 4, 2013
- 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-36977
Recalled products
- Toothed Rack Retractor, for Matrix
- Removal Tool for T-PAL
Reason
Synthes was notified by its supplier that within one material batch used for production of the affected parts one or several bars were mixed in with an incorrect material. Specified material was 420A and material of the mixed in bar(s) was X20CRMNNI 12 8 6 (which is a non-magnetic austenitic steel grade used for electric generators). The wrong material results in lower than specified hardness and corrosion resistance.
Affected products
A. Toothed Rack Retractor, for Matrix
Lot or serial number
- T987270
Model or catalog number
- 03.632.087
Companies
- Manufacturer
-
Synthes (Canada) Ltd.
2566 Meadowpine Blvd.
Mississauga
L5N 6P9
Ontario
CANADA
B. Removal Tool for T-PAL
Lot or serial number
- T987623
Model or catalog number
- 03.812.005
Companies
- Manufacturer
-
Synthes (Canada) Ltd.
2566 Meadowpine Blvd.
Mississauga
L5N 6P9
Ontario
CANADA