FOOTPRINT Ultra PK Suture Anchor,4.5mm; 5.5mm (2020-03-19)
- Starting date:
- March 19, 2020
- Posting date:
- April 17, 2020
- 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-72801
Last updated: 2020-04-17
Affected Products
FOOTPRINT Ultra PK Suture Anchor,4.5mm; 5.5mm
Reason
Smith &Amp; Nephew, Inc., has initiated a voluntary recall to remove specific lots of the FOOTPRINT Ultra PK Suture Anchor due to a packaging design related issue. The space between the device and the packaging permits excessive movement, which could potentially lead to the displacement of the anchor's tip protector allowing the tip of the anchor to create a sterile breach.
Affected products
FOOTPRINT Ultra PK Suture Anchor,4.5mm; 5.5mm
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
- 72202901
- 72202902
Companies
- Manufacturer
-
Smith & Nephew, Inc., Endoscopy Division
150 Minuteman Road
Andover
01810
Massachusetts
UNITED STATES