FDA Medical Device Recalls (openFDA)
Genzyme Corporation: Genzyme Biosurgery Essentials Kit, Item Number 82004
- Recall number
- Z-2310-2010
- Recalling firm
- Genzyme Corporation
- Product
- Genzyme Biosurgery Essentials Kit, Item Number 82004
- Status
- Terminated
- Initiated
- 2010-07-13
- Posted
- 2010-08-28
- Terminated
- 2012-01-30
- Reason
- 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
- 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
- 3132 kits
- Distribution
- Nationwide
- Lot, serial or model codes
- Lot Numbers Affected: RM00654 RM00664 RM00672 RM00687 RM00690 RM00698 RM00700 RM00711 RM00714 RM00727 RM00732 RM00741 RM00748 RM00757 RM00773 RM00781 RM00791 RM00802 RM00820 RM00835
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- LRO
- Firm FEI
- 3002836339
- Firm city
- Cambridge
- Firm state
- MA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28