Recall Z-1757-2020— Smith & Nephew, Inc.
Class II · Ongoing
Class II FDA medical device recall by Smith & Nephew, Inc., initiated 2020-03-17. It names one FDA 510(k) clearance: K093897. Product: Smith & Nephew FOOTPRINT Ultra PK Suture Anchor, 5.5mm Part Number: 72202902. Reason: 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..
- Recalling firm
- Smith & Nephew, Inc.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2020-03-17
- Firm location
- Mansfield, MA, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
Smith & Nephew FOOTPRINT Ultra PK Suture Anchor, 5.5mm Part Number: 72202902
Reason for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.