Ascension PyroCarbon PIP Total Joint - Trials; Ascension PIP, sizes 10P, 20P, 30P and 40P. Ascension Orthopedics, 8700 Cameron Road, Suite 100, Austin, Texas 78754; TEL: 512 836-5001. Intended as an accessory to the Ascension PyroCarbon PIP Total Joint used in finger joint implant procedures where the joint has become painful, stiff or cannot move because of arthritis.
- Company
- Ascension Orthopedics, Inc
- Recall Initiated
- June 17, 2009
- Posted
- May 4, 2010
- Terminated
- September 27, 2010
- Recall Number
- Z-1524-2010
- Quantity
- 129 units (64 US, 65 OUS)
- Firm Location
- Austin, TX
Reason for Recall
Trial product was larger than actual implant. Trial product was re-designed to more closely match the implant.
Distribution
Worldwide Distribution - Worldwide Distribution - United States, United Kingdom, France, Australia, Belgium, Czech Republic, Canada, Germany, The Netherlands and South Africa.
Lot / Code Info
All lot codes.
Root Cause
Device Design
Action Taken
Ascension Orthopedics, Inc. issued e-mail notification to distributors and sales representatives beginning June 2009. Consignees were instructed return affected product to the firm for replacement. For further information, contact Ascension Orthopedics, Inc. at 1-512-836-5001 extension 1549.
More recalls by Ascension Orthopedics, Inc
Ascension Orthopedics First Choice Partial Ulnar Head System ("DRUJ System"). Head sizes 14.5 mm, 1...
Feb 17, 2012
The Ascension PyroHemiSphere (aka NuGrip), Model #40-M NUG-443-40M, Catalog #NUG-443-40M, Lot #10-04...
Nov 22, 2010