Z-1833-2011

REF 32-485050 VANGUARD KNEE INSTRUMENTATION MICROPLASTY SLIDEX ANTERIOR/POSTERIOR, QTY: 1 The guide is used...

Name: Z-1833-2011 REF 32-485050 VANGUARD KNEE INSTRUMENTATION MICROPLASTY SLIDEX ANTERIOR/POSTERIOR, QTY: 1 The guide is used...
Creator: Biomet, Inc.
Published: 2011-02-10
License: https://open.fda.gov/license/

Zimmer GmbH / initiated 2011-02-10 / Terminated

FDA source

Biomet, Inc. began a recall of REF 32-485050 VANGUARD KNEE INSTRUMENTATION MICROPLASTY SLIDEX ANTERIOR/POSTERIOR, QTY: 1 The guide is used for femoral sizing - Neutral or 3 degree femoral... on 2011-02-10. The reason FDA records is "Biomet has initiated this action due to the scale on the stylus of the Vanguard MP Slldex AP Sizer being incorrect for this assembly resulting in the scale being out of position". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1833-2011
Status: Terminated
Initiated: 2011-02-10
Posted: 2011-03-28
Terminated: 2011-05-16
Recalling firm: Zimmer GmbH
Product: REF 32-485050 VANGUARD KNEE INSTRUMENTATION MICROPLASTY SLIDEX ANTERIOR/POSTERIOR, QTY: 1 The guide is used for femoral sizing - Neutral or 3 degree femoral rotation feet are attached to the slidex AP sizing guide.
Product code: FZX Guide, Surgical, Instrument
Reason for recall: Biomet has initiated this action due to the scale on the stylus of the Vanguard MP Slldex AP Sizer being incorrect for this assembly resulting in the scale being out of position.
FDA root cause: Process change control
Action: The firm, Biomet, sent a "FIELD SAFETY NOTICE" dated February 11, 2011 to all customers (heads of Orthopaedic Departments/Operating Departments /Sterile Services Departments/Procurement /Supplies/ Risk Management). The notice described the product, problem and actions to be taken. The customers were instructed to immediately locate and discontinue use of the product; return to Biomet or their local Biomet distributor; ensure that the operating staff are made aware of this issue, and complete and return the FAX BACK RESPONSE FORM to Biomet UK Ltd or their local Biomet distributor via fax at +44 (0) 1656 645454. If you have any questions regarding this communication, please contact the Regulatory & Compliance Manager at +44 (0) 1793 645317 or email: [email protected].
Quantity in commerce: 17
Distribution: Foreign only; UK, Malta, The Netherlands, Italy, Turkey, Switzerland.
Product codes and lots: LOT 32-485050 LOT NO. SA10 81254

Product code FZX

The FDA recall record names no cleared device, and no clearance has been matched to it.

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)