Z-2310-2010

Genzyme Biosurgery Essentials Kit, Item Number 82004

Name: Z-2310-2010 Genzyme Biosurgery Essentials Kit, Item Number 82004
Creator: Genzyme Corporation
Published: 2010-07-13
License: https://open.fda.gov/license/

Genzyme Corporation / initiated 2010-07-13 / Terminated / root cause: labeling and UDI

FDA source

Genzyme Corporation began a recall of Genzyme Biosurgery Essentials Kit, Item Number 82004 on 2010-07-13. The reason FDA records is "Revised Labeling of Carticel Essentials Kit clarifies the non-sterile packaging of the outer clear plastic tray which should not be opened in the sterile field". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-2310-2010
Status: Terminated
Initiated: 2010-07-13
Posted: 2010-08-28
Terminated: 2012-01-30
Recalling firm: Genzyme Corporation
Product: Genzyme Biosurgery Essentials Kit, Item Number 82004
Product code: LRO General Surgery Tray
Reason for recall: Revised Labeling of Carticel Essentials Kit clarifies the non-sterile packaging of the outer clear plastic tray which should not be opened in the sterile field.
Root cause tag: labeling and UDI
FDA root cause: Labeling design
Action: Genzyme notiifed physicians with the Dear Doctor letter on July 13, 2010 via UPS Ground delivery. The letter informed healthcare workers of the recent incidents and advise them to heed the Essentials Kit label and exercise proper handling of the Kit.. A fax return form will be provided for the physician to sign and return to Genzyme to acknowledge receipt of the notification. Contact Genzyme Medical Information at 800-453-6948, option #3 for any additional information or contact your Genzyme sales representative with any questions.
Quantity in commerce: 3132 kits
Distribution: Nationwide
Product codes and lots: Lot Numbers Affected: RM00654 RM00664 RM00672 RM00687 RM00690 RM00698 RM00700 RM00711 RM00714 RM00727 RM00732 RM00741 RM00748 RM00757 RM00773 RM00781 RM00791 RM00802 RM00820 RM00835

Product code LRO

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)