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All-Suture Anchor Twist Drill for All-Suture Anchors Inline Drill Guide for All-Suture Anchors

by Smith & Nephew, Inc.

510(k) K122059

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

1 ongoing

This device is named in the recall

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK122059 Date18 Mar 2013ClearedStatusActive

Recalls

6 recalls · 1 ongoing · FDA

    • Ongoing Z-2746-2020 FDA Class II initiated 24 Jun 2020

    A packaging error resulted in a XL drill being presented for use instead of the S drill. The XL drill is one inch longer than the S drill.

  • 5 recalls, same reason

    • Terminated Z-2047-2014 FDA Class II initiated 2 Jun 2014
    • Terminated Z-2049-2014 FDA Class II initiated 2 Jun 2014
    • Terminated Z-2046-2014 FDA Class II initiated 2 Jun 2014
    • Terminated Z-2048-2014 FDA Class II initiated 2 Jun 2014
    • Terminated Z-2045-2014 FDA Class II initiated 2 Jun 2014

    Sterility of device is compromised due to breach in sterile barrier

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
MBI
Device Class
Class II
Regulation
21 CFR Part 888.3040
Advisory Committee
Orthopedic
FDA Decision
SESE Substantially Equivalent

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