Revitan Modular Rasp Distal Curved and Revitan Rasp Distal Curved (2017-12-27)
- Starting date:
- December 27, 2017
- Posting date:
- January 29, 2018
- 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-65778
Affected products
- Revitan Modular Rasp, Distal Curved
- Revitan Rasp Distal Curved
Reason
The current issue deals with potential breakage of the instrument intra-operatively after an extensive use over time. There is a potential risk for breakage of the rasps during the surgery. The cause for the reported breakage can be multifactorial.
Affected products
A. Revitan Modular Rasp, Distal Curved
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
- 01.00409.612
- 01.00409.613
- 01.00409.614
- 01.00409.617
- 01.00409.622
- 01.00409.623
- 01.00409.624
- 01.00409.625
- 01.00409.626
- 01.00409.627
- 01.00409.628
- 01.00409.629
- 01.00409.633
- 01.00409.634
- 01.00409.635
- 01.00409.636
- 01.00409.637
- 01.00409.638
- 01.00409.639
Companies
- Manufacturer
-
Zimmer GmbH
Sulzer Allee 8
Winterthur
8404
SWITZERLAND
B. Revitan Rasp Distal Curved
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
- 01.00409.612
- 01.00409.613
- 01.00409.614
Companies
- Manufacturer
-
Zimmer GmbH
Sulzer Allee 8
Winterthur
8404
SWITZERLAND