Recall Z-3096-2024— Smith & Nephew Inc.
Class II · Ongoing
Class II FDA medical device recall by Smith & Nephew Inc., initiated 2024-08-12. It names one FDA 510(k) clearance: K131637. Product: ROTATION MEDICAL TENDON STAPLES (8) (broad indication)-Intended for fixation of prosthetic material to soft tissues. Product Number: 2504-1. Reason: Product packaging process may result in an improper or incomplete seal of the outer foil pouch surrounding the inner Tyvek pouch, compromising product sterility.
- Recalling firm
- Smith & Nephew Inc.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2024-08-12
- Firm location
- Andover, 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
ROTATION MEDICAL TENDON STAPLES (8) (broad indication)-Intended for fixation of prosthetic material to soft tissues. Product Number: 2504-1
Reason for recall
Product packaging process may result in an improper or incomplete seal of the outer foil pouch surrounding the inner Tyvek pouch, compromising product sterility
Data sourced from openFDA. This site is unofficial and independent of the FDA.