FDA Medical Device Recalls (openFDA)
Avanta Orthopaedics, Inc.: Finger Joint Implants, Silicone Models TRL-10 and TRL-20
- Recall number
- Z-0710-03
- Recalling firm
- Avanta Orthopaedics, Inc.
- Product
- Finger Joint Implants, Silicone Models TRL-10 and TRL-20
- Status
- Terminated
- Initiated
- 2003-01-24
- Posted
- 2003-04-09
- Terminated
- 2004-12-01
- Reason
- Wrong silicone elastomer used in construction.
- Root cause
- Other
- Action
- Recall was initiated by telephone on 1/24/2003. All customers responded by 1/28/2003. All units have been accounted for. The units have been returned. The recall is complete.
- Quantity
- 43
- Distribution
- States of CA and UT and to France.
- Lot, serial or model codes
- TRL-10, Lot 45275002, 13 units shipped TRL-20, Lot 45186001, 30 units shipped
- 510(k) numbers
- ["K964381"]
- PMA numbers
- not on file
- Product code
- KYI
- Firm FEI
- 1000519983
- Firm city
- San Diego
- Firm state
- CA
- 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