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Synthes Rods (2016-10-14)
- Starting date:
- October 14, 2016
- Posting date:
- November 9, 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-60946
Affected Products
A. REAMING ROD W/BALL TIP
B. REAMING ROD W/STRAIGHT BALL TIP
C. GUIDE ROD WITH SMOOTH TIP - STERILE
Reason
The peel pouches for the affected reaming rods and extraction hooks are delaminating. The surgical staff members may experience difficulty in opening the peel pouch potentially causing the sterile device to come in contact with a non-sterile layer of the pouch.
Affected products
A. REAMING ROD W/BALL TIP
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
351.707S
351.709S
Companies
- Manufacturer
-
Synthes USA LLC
1101 SYNTHES AVENUE
Monument
80132
UNITED STATES
B. REAMING ROD W/STRAIGHT BALL TIP
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
351.76S
359.083S
Companies
- Manufacturer
-
Synthes USA LLC
1101 SYNTHES AVENUE
Monument
80132
UNITED STATES
C. GUIDE ROD WITH SMOOTH TIP - STERILE
Lot or serial number
H085634
H085635
H087271
H094462
H094463
H111419
H136756
Model or catalog number
355.041S
355.042S
Companies
- Manufacturer
-
Synthes USA LLC
1101 SYNTHES AVENUE
Monument
80132
UNITED STATES