Recall Z-0147-2021— Smith & Nephew, Inc.

Name: FDA recall Z-0147-2021
Creator: U.S. Food and Drug Administration
Published: 2020-09-09

Class II · Ongoing

Class II FDA medical device recall by Smith & Nephew, Inc., initiated 2020-09-09. It names one FDA 510(k) clearance: K151105. Product: RAPTORMITE 3.7MM AB W/ NEEDLES AND TWO-Absorbable Suture anchor Product Number: 72201805. Reason: Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a breach of the sterile barrier created by the pouch.

Recalling firm: Smith & Nephew, Inc.
Classification: Class II
Status: Ongoing
Initiated: 2020-09-09
Firm location: Andover, MA, United States

510(k) clearances named in this recall

1 on FDA's record

K151105 — Smith and Nephew Suture Anchors - 5.0mm Absorbable Polymer Anchor, Smith and Nephew Suture Anchors - TAG Bioraptor Suture Anchor 7209317, 7209318, Smith and Nephew Suture Anchors - Bioraptor 2.3 PK Suture Anchor, Smith and Nephew Suture Anchors - Osteoraptor Suture Anchor, Smith and Nephew Suture Anchors - Twinfix Ultra HA Suture Anchor, Smith and Nephew Suture Anchors - OSTEORAPTOR Curved Suture Anchors, Smith and Nephew Suture Anchors - Ultra Fast-Fix Meniscal Repair System, Ultra FaSmith & Nephew, Inc.·cleared 2015-07-28

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

RAPTORMITE 3.7MM AB W/ NEEDLES AND TWO-Absorbable Suture anchor Product Number: 72201805

Reason for recall

Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a breach of the sterile barrier created by the pouch

Data sourced from openFDA. This site is unofficial and independent of the FDA.