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Exeter 0920-2-920

by Howmedica Osteonics Corp.

Exeter 0920-2-920 is a Class II device made by Howmedica Osteonics Corp., cleared under FDA 510(k) K191414 on 28 Aug 2019 (1 earlier submission) and listed in FDA GUDID since 24 Sep 2015 (UDI-DI 04546540166715), active as of 23 Oct 2026. 3 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

None ongoing

3 closed

Documents

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK191414 Date28 Aug 2019DecidedStatusActive
United StatesGUDID listing Number04546540166715 UDI-DI Date24 Sep 2015ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • FDA 510(k) K191414 decided 28 Aug 2019 Active· +1 more in the status table
  • FDA GUDID UDI-DI 04546540166715 listed 24 Sep 2015 Listed

Recalls

3 recalls · FDA

  • 2 recalls, same reason

    • Terminated Z-1594-2010 FDA Unclassified (pre-2012) initiated 31 Mar 2010
    • Terminated Z-1593-2010 FDA Unclassified (pre-2012) initiated 31 Mar 2010

    One lot of 13 mm medium distal ring centralizers and 14 mm large distal ring centralizer have been labeled incorrectly. The size 14 Large centralizers have been labeled as size 13 Medium centralizers and size 13 Medium centralizers have been labeled as size 14 Large centraliizers.

    • Terminated Z-1601-2010 FDA Unclassified (pre-2012) initiated 29 Mar 2010

    Stryker became aware that device labels have incorrectly printed manufacture dates and thus incorrect expiration dates on the product label.

Timeline

6 dated events

  1. Cleared FDA 510(k) K974054
  2. Recall initiated FDA recalls Z-1601-2010
  3. Recall initiated FDA recalls Z-1594-2010
  4. Recall initiated FDA recalls Z-1593-2010
  5. Listed FDA GUDID 04546540166715
  6. Cleared FDA 510(k) K191414

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Exeter
Generic name
Polymer orthopaedic cement restrictor, non-bioabsorbable
Model / Ref / Catalog
0920-2-920
Primary DI / UDI-DI
04546540166715
FDA product code
JDI, LZN
GMDN term
Polymer orthopaedic cement restrictor, non-bioabsorbable
Device class
Class II
Regulation number
888.3350, 878.3300
GUDID distribution status
In Commercial Distribution
MRI safety
MR Conditional
Size
Length — 2.5 Millimeter

Related devices

Category: Polymer orthopaedic cement restrictor, non-bioabsorbable

Cleared under the same submission (K191414)

and 4 more cleared under K191414

Other devices from Howmedica Osteonics Corp.

See all devices from Howmedica Osteonics Corp. →

Properties

  • Supplied sterile
  • Single use
  • Implantable
  • Prescription use
  • Lot / batch number
Other properties (10, all answered No)