Z-0710-03

Finger Joint Implants, Silicone Models TRL-10 and TRL-20

Name: Z-0710-03 Finger Joint Implants, Silicone Models TRL-10 and TRL-20
Creator: Avanta Orthopaedics, Inc.
Published: 2003-01-24
License: https://open.fda.gov/license/

Avanta Orthopaedics, Inc. / initiated 2003-01-24 / Terminated

FDA source

Avanta Orthopaedics, Inc. began a recall of Finger Joint Implants, Silicone Models TRL-10 and TRL-20 on 2003-01-24. The reason FDA records is "Wrong silicone elastomer used in construction". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0710-03
Status: Terminated
Initiated: 2003-01-24
Posted: 2003-04-09
Terminated: 2004-12-01
Recalling firm: Avanta Orthopaedics, Inc.
Product: Finger Joint Implants, Silicone Models TRL-10 and TRL-20
Product code: KYI Prosthesis, Wrist, Carpal Trapezium
Reason for recall: Wrong silicone elastomer used in construction.
FDA 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 in commerce: 43
Distribution: States of CA and UT and to France.
Product codes and lots: TRL-10, Lot 45275002, 13 units shipped TRL-20, Lot 45186001, 30 units shipped

Product code KYI

K964381Class IIAvanta Orthopaedics Trapezial ImplantAvanta Orthopaedics, Inc. / cleared 1997-01-22

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)