Recall Z-0581-2025— Smith & Nephew Inc.
Class II · Ongoing
Class II FDA medical device recall by Smith & Nephew Inc., initiated 2024-10-29. It names 2 FDA 510(k) clearances: K152566, K071586. Product: BIORAPTOR Suture Anchors. Tendon/ligament, non-bioabsorbable bone anchor.. Reason: Sterile barrier breach due to inadequate packaging design that could not hold the geometry of the device..
- Recalling firm
- Smith & Nephew Inc.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2024-10-29
- Firm location
- Andover, MA, United States
510(k) clearances named in this recall
2 on FDA's record- K152566 — PEBA Anchor/Suture Combination, 2.0mm Mini-Tac Anchor, Model 10-1629-01, Modification to Twinfix Ti Quick-T, Twinfix FT PK, Twinfix Ultra Ti, Twinfix Ultra PK, Twinfix Ultra HA Suture Anchors, FOOTPRINT Ultra OK Suture Anchors, BIORAPTOR 2.9 Suture Anchor, BIORAPTOR 2.3 PK Suture Anchor, OSTEORAPTOR Suture Anchor, BIORAPTOR Knotless Suture Anchor, HEALICOIL PK Suture Anchor (formerly Next Generation Fully Threaded Suture Anchor), Bioraptor Curved 2.3 PK Suture Anchors
- K071586 — BIORAPTOR 2.3 PK SUTURE ANCHOR
K-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
BIORAPTOR Suture Anchors. Tendon/ligament, non-bioabsorbable bone anchor.
Reason for recall
Sterile barrier breach due to inadequate packaging design that could not hold the geometry of the device.
Data sourced from openFDA. This site is unofficial and independent of the FDA.