Z-0555-2010

Zimmer, Insall/Burstein II Modular Knee System, Tibial Wedge and 2 Screws, Size 59, 7 Deg. x 9.5 mm Height...

Name: Z-0555-2010 Zimmer, Insall/Burstein II Modular Knee System, Tibial Wedge and 2 Screws, Size 59, 7 Deg. x 9.5 mm Height...
Creator: Zimmer Inc.
Published: 2009-02-26
License: https://open.fda.gov/license/

Zimmer GmbH / initiated 2009-02-26 / Terminated / root cause: manufacturing process

FDA source

Zimmer Inc. began a recall of Zimmer, Insall/Burstein II Modular Knee System, Tibial Wedge and 2 Screws, Size 59, 7 Deg. x 9.5 mm Height, Tivanium TI-6AL-4V Alloy, sterile; REF 5220-62-01 on 2009-02-26. The reason FDA records is "Smaller diameter screws than required were included in the package". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0555-2010
Status: Terminated
Initiated: 2009-02-26
Posted: 2009-12-22
Terminated: 2011-02-28
Recalling firm: Zimmer GmbH
Product: Zimmer, Insall/Burstein II Modular Knee System, Tibial Wedge and 2 Screws, Size 59, 7 Deg. x 9.5 mm Height, Tivanium TI-6AL-4V Alloy, sterile; REF 5220-62-01.
Product code: HSX Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer
Reason for recall: Smaller diameter screws than required were included in the package.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Zimmer notified consignees by recall letter dated 2/25/09 instructing them to cease use of the device and to return it. Zimmer distributors and international accounts were notified by email on 2/26/09.
Quantity in commerce: 13
Distribution: USA (Connecticut, Indiana, Pennsylvania), Australia, Serbia, Spain, Switzerland and the United Kingdom.
Product codes and lots: Lot 07878240.

Product code HSX

K862632Class IIInsall/burstein(tm)* II Tibial WedgesZimmer, Inc. / cleared 1987-03-25

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)