Ascension Orthopedics, Inc.
11101 Metric Blvd, Austin, TX, US
Registered product codes
3 product codes
Recent MDR events
992 on file
- BASEPLATE/GLENOSPHERE INSERTERJul 21, 2026Malfunction3002788818-2026-00090
- GLENOID INSERTER TIP MJul 18, 2026Malfunction3002788818-2026-00089
- LINER TRIAL HEIGHT +0MMJul 15, 2026Malfunction3002788818-2026-00088
- LINER TRIAL HEIGHT +0MMJul 14, 2026Malfunction3002788818-2026-00086
- BASEPLATE/GLENOSPHERE INSERTERJul 14, 2026Malfunction3002788818-2026-00087
- 4.5MM CENTER SCREW 30MMJul 13, 2026Malfunction3002788818-2026-00085
- HUMERAL HEAD TRL 47X16 CONCENTRICJun 30, 2026Malfunction3002788818-2026-00084
- BASEPLATE/GLENOSPHERE INSERTERJun 22, 2026Malfunction3002788818-2026-00083
- 15 DEG AUGMENT BASEPLATE FULL WEDGEJun 17, 2026Injury3002788818-2026-00082
- LINER TRIAL HEIGHT +0MMJun 12, 2026Malfunction3002788818-2026-00081
Recalls
9 on file
- TerminatedFeb 17, 2012
A recent review conducted by Ascension Orthopedics revealed that certain modifications were made to the First Choice System and should have been preceded by a submission of a filing with the FDA.
View FDA record ↗ - TerminatedNov 22, 2010
Two different product lots were found to be incorrectly labeled and placed into the incorrect box.
View FDA record ↗ - TerminatedNov 22, 2010
Two different product lots were found to be incorrectly labeled and placed into the incorrect box.
View FDA record ↗ - TerminatedMay 4, 2010
Trial product was larger than actual implant. Trial product was re-designed to more closely match the implant.
View FDA record ↗ - TerminatedJun 26, 2009
Screwdriver used with the Ascension Total Foot System not manufactured to specification, resulting in the driver not properly engaging and/or stripping the screws making it difficult to properly seat the screws during surgery.
View FDA record ↗ - TerminatedJul 20, 2004
Cracks in the tray due to excessive use can cause perforations in the outer wrap used to maintain instrument tray sterility.
View FDA record ↗ - TerminatedFeb 8, 2003
Brochures approved for international distribution only were distributed domestically.
View FDA record ↗ - TerminatedFeb 8, 2003
Literature approved for international distribution only was distributed domestically.
View FDA record ↗ - TerminatedUnknown
The product was packaged with the Instructions for Use for a different product (Ascension First Choice DRUJ System Partial Ulnar Head Implant).
View FDA record ↗
Compliance history
Matched by FEI 3002788818.
FDA inspections
0 on file
No inspections on file for this FEI number.
Inspection citations
0 on file
No citations on file for this FEI number.
Compliance actions
0 on file
No warning letters or injunctions on file for this FEI number.
Import refusals
0 on file
No import refusals on file for this FEI number.