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Reaming Rod with Ball Tip and Guide Rod with Smooth Tip (2017-07-25)
- Starting date:
- July 25, 2017
- Posting date:
- September 5, 2017
- 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-64380
Affected Products
A. Reaming Rod W/Ball Tip
B. Reaming Rod W/Straight Ball Tip
C. Guide Rod With Smooth Tip - Sterile
- Reaming Rod W/Ball Tip
- Reaming Rod W/Straight Ball Tip
- Guide Rod With Smooth Tip - Sterile
Reason
During an open peel test, it was identified that the seals for a reaming rod sealed in packaging aids corporation jaw sealer machine had gaps/channeling in the seals, therefore, resulting in the potential for non-sterile product. Recall initiated due to potential gaps/channeling in the seal of the package.
Affected products
A. Reaming Rod W/Ball Tip
Lot or serial number
- H294402
- H297335
- H297386
- H325600
- H333939
- H342583
Model or catalog number
351.706S
Companies
- Manufacturer
-
Synthes USA LLC
1101 SYNTHES AVENUE
Monument
80132
UNITED STATES
B. Reaming Rod W/Straight Ball Tip
Lot or serial number
H270855
H306632
H311231
H327067
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
H354470
Model or catalog number
355.042S
Companies
- Manufacturer
-
Synthes USA LLC
1101 SYNTHES AVENUE
Monument
80132
UNITED STATES