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Djo Surgical 520-42-216

by Encore Medical LP

Djo Surgical 520-42-216 is a Class II device made by Encore Medical LP, cleared under FDA 510(k) K162024 on 21 Nov 2016 and listed in FDA GUDID since 17 Jan 2017 (UDI-DI 00190446176091), active as of 8 Nov 2026. 6 FDA recalls are linked to it.

Active United States. Also listed in GUDID (US).

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

510(k) K162024

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 8 Nov 2026.

Regulatory status

as of registry sync 8 Nov 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00190446176091 UDI-DI Date17 Jan 2017ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK162024 Date21 Nov 2016DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K162024 decided 21 Nov 2016 Active
  • FDA GUDID UDI-DI 00190446176091 listed 17 Jan 2017 Listed

Recalls

6 recalls · 1 ongoing · FDA

    • Ongoing Z-2331-2021 FDA Class II initiated 28 Jun 2021

    Complaints have been received concerning the humeral stem failing to mate with the broach handles for a shoulder device. This could result in delay of procedure or revision surgery.

  • 5 recalls, same reason

    • Completed Z-1256-2018 FDA Class II initiated 29 Jan 2018
    • Completed Z-1260-2018 FDA Class II initiated 29 Jan 2018
    • Completed Z-1257-2018 FDA Class II initiated 29 Jan 2018
    • Completed Z-1258-2018 FDA Class II initiated 29 Jan 2018
    • Completed Z-1259-2018 FDA Class II initiated 29 Jan 2018

    It was discovered during a surgery that the design of the radius at the base of the pegs of the Anatomic Glenoid Trial (Part Numbers: 804-07-380, 804-07-420, 804-07-460, 804-07-500, and 804-07-540) is much larger on the trails than on the implants

Timeline

8 dated events

  1. Cleared FDA 510(k) K162024
  2. Listed FDA GUDID 00190446176091
  3. Recall initiated FDA recalls Z-1256-2018
  4. Recall initiated FDA recalls Z-1260-2018
  5. Recall initiated FDA recalls Z-1257-2018
  6. Recall initiated FDA recalls Z-1258-2018
  7. Recall initiated FDA recalls Z-1259-2018
  8. Recall initiated FDA recalls Z-2331-2021

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Djo Surgical
Generic name
Total shoulder prosthesis
Model / reference
520-42-216
Primary DI / UDI-DI
00190446176091
510(k) Number
FDA product code
PAO, KWS, HSD
GMDN term
Total shoulder prosthesis
Device class
Class II
Regulation number
888.3660, 888.3690
GUDID distribution status
In Commercial Distribution

Related devices

Category: Total shoulder prosthesis

Cleared under the same submission (K162024)

and 8 more cleared under K162024

Other devices from Encore Medical LP

See all devices from Encore Medical LP →

Properties

  • Supplied sterile
  • Implantable
  • Lot / batch number
  • Expiration date
Other properties (11, all answered No)