Z-1589-2011

Biomet INNERVUE DISPOSABLE SCOPE KIT 1.2MM WITH CANNULA SET, PRODUCT NUMBER 922141, STERILE

Name: Z-1589-2011 Biomet INNERVUE DISPOSABLE SCOPE KIT 1.2MM WITH CANNULA SET, PRODUCT NUMBER 922141, STERILE
Creator: Biomet, Inc.
Published: 2011-02-10
License: https://open.fda.gov/license/

Zimmer GmbH / initiated 2011-02-10 / Terminated / root cause: manufacturing process

FDA source

Biomet, Inc. began a recall of Biomet INNERVUE DISPOSABLE SCOPE KIT 1.2MM WITH CANNULA SET, PRODUCT NUMBER 922141, STERILE on 2011-02-10. The reason FDA records is "The cannula could not be connected to the scope and scopes disengage during use. The outer hub of Innervue scopes may become detached from the inner hub of the scopes during assembly of the scope to the Innervue hand...". 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-1589-2011
Status: Terminated
Initiated: 2011-02-10
Posted: 2011-03-07
Terminated: 2013-08-27
Recalling firm: Zimmer GmbH
Product: Biomet INNERVUE DISPOSABLE SCOPE KIT 1.2MM WITH CANNULA SET, PRODUCT NUMBER 922141, STERILE
Product code: HRX Arthroscope
Reason for recall: The cannula could not be connected to the scope and scopes disengage during use. The outer hub of Innervue scopes may become detached from the inner hub of the scopes during assembly of the scope to the Innervue hand piece. This condition may prevent the Innervue scope from being securely attached to the Innervue hand piece.
Root cause tag: manufacturing process
FDA root cause: Process design
Action: On 2/10/2011, Biomet issued an "URGENT MEDICAL DEVICE NOTICE" to their Direct Accounts instructing customers to identify and discontinue use of the recalled products and return them to Biomet. Response forms were provided.
Quantity in commerce: 264
Distribution: Distribution USA nationwide and to the Netherlands
Product codes and lots: PART NUMBER 922141, LOT NUMBERS-649680, 818630, 390060, 968890, 783990, 784000

Product code HRX

K072879Class IIInnervue Diagnostic Scope SystemBiomet Orthopedics, Inc. / cleared 2008-01-14

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)