Skip to content

1109-11

by Zimmer, Inc. 2 variants

1109-11 is a Class II device made by Zimmer, Inc., cleared under FDA 510(k) K001733 on 20 Jun 2000 (2 earlier submissions) and listed in FDA GUDID since 15 Jul 2016 (UDI-DI 00889024432918), active as of 22 Oct 2026. 4 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

4 closed

Documents

Trust

Unverified

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00889024432918 UDI-DI Date15 Jul 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK001733 Date20 Jun 2000DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K001733 decided 20 Jun 2000 Active· +2 more in the status table
  • FDA GUDID UDI-DI 00889024432918 listed 15 Jul 2016 Listed

Recalls

4 recalls · FDA

  • 2 recalls, same reason

    • Terminated Z-1164-2016 FDA Class II initiated 11 Jan 2016
    • Terminated Z-1167-2016 FDA Class II initiated 11 Jan 2016

    As a result of the insufficient sealer calibration data for product packaged in firm's Building II between August 2010 and April 2013. The affected products are sterile.

    • Terminated Z-1029-2014 FDA Class II initiated 11 Oct 2013

    Zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufacturing B.V. (ZMBV) facility in Ponce, Puerto Rico. Based on this review, it was determined that the packaging operations conducted in the Building 1 packaging operation at this facility were not properly validated. As a result, Zimmer conducted seal integrity testing to evaluate if previously packaged product from this facility met the established requirements for sterile barrier integrity. The acceptance criteria established for this testing was 99% reliability with a 90% confidence interval. These packaging tray configurations met the acceptance criteria for sterile barrier integrity of both the inner and outer trays, however, Zimmer has decided to recall all manufacturing lots that have not expired and that were sterile packaged in the ZMBV facility Building 1 packaging operations.

    • Terminated Z-1699-2009 FDA Unclassified (pre-2012) initiated 8 Jun 2009

    The seal on the sterile barrier pouch may be inadequate, resulting in lack of assurance of sterility.

Timeline

8 dated events

  1. Cleared FDA 510(k) K800142
  2. Cleared FDA 510(k) K950312
  3. Cleared FDA 510(k) K001733
  4. Recall initiated FDA recalls Z-1699-2009
  5. Recall initiated FDA recalls Z-1029-2014
  6. Recall initiated FDA recalls Z-1164-2016
  7. Recall initiated FDA recalls Z-1167-2016
  8. Listed FDA GUDID 00889024432918

Coverage

1 jurisdiction

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

United States — FDA 510(k) Active

Specification

GUDID

Generic name
Polymer orthopaedic cement restrictor, non-bioabsorbable
Model / reference
1109-11
Primary DI / UDI-DI
00889024432918
510(k) Number
FDA product code
JDI, JDS, LZN
GMDN term
Polymer orthopaedic cement restrictor, non-bioabsorbable
Device class
Class II
Regulation number
888.3350, 888.3030, 878.3300
GUDID distribution status
In Commercial Distribution

Related devices

Category: Polymer orthopaedic cement restrictor, non-bioabsorbable

Cleared under the same submission (K001733)

and 5 more cleared under K001733

Cleared under the same submission (K800142)

Other devices from Zimmer, Inc.

See all devices from Zimmer, Inc. →

Properties

  • Supplied sterile
  • Single use
  • Implantable
  • Contains latex
  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (8, all answered No)