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Arthrex Inc. SwiveLocks (2017-03-27)
- Starting date:
- March 27, 2017
- Posting date:
- May 2, 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-63134
Affected Products
- Bio-SwiveLock, Self-Punching
- Bio-Composite SwiveLock, Self-Punching
- Peek SwiveLock, Self-Punching
- Speedbridge Implant System With Biocomposite SwiveLock SP (Shoulder)
Reason
The self-punching eyelet contained within the Arthrex Swivelock SP suture anchor has the potential to break on insertion in hard cortical bone. There is no impact to the patient if the device has been implanted successfully.
Affected products
A. Bio-SwiveLock, Self-Punching
Lot or serial number
10078259
Model or catalog number
AR-2323BSLM
Companies
- Manufacturer
-
Arthrex Inc.
1370 Creekside Boulevard
Naples
34108-1945
Florida
UNITED STATES
B. Bio-Composite SwiveLock, Self-Punching
Lot or serial number
10072425
10073992
10075792
10077133
10078077
10078340
Model or catalog number
AR-2324BCM
Companies
- Manufacturer
-
Arthrex Inc.
1370 Creekside Boulevard
Naples
34108-1945
Florida
UNITED STATES
C. Peek SwiveLock, Self-Punching
Lot or serial number
10072597
10078258
Model or catalog number
AR-2323PSLM
AR-2324PSLM
Companies
- Manufacturer
-
Arthrex Inc.
1370 Creekside Boulevard
Naples
34108-1945
Florida
UNITED STATES
D. Speedbridge Implant System With Biocomposite SwiveLock SP (Shoulder)
Lot or serial number
10070003
10074288
10074291
10075965
10076753
10076852
10077252
10081420
10084027
Model or catalog number
AR-2600SBS-5
AR-2600SBS-7
Companies
- Manufacturer
-
Arthrex Inc.
1370 Creekside Boulevard
Naples
34108-1945
Florida
UNITED STATES