Ascension MCP, Prosthesis, Finger Joint, Metacarpophalangeal recallZ-0550-03 · Ascension Orthopedics, Inc · initiated Oct 31, 2002
Terminated All recalls posted in February 2003
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Ascension Orthopedics, Inc or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Literature approved for international distribution only was distributed domestically.
FDA root cause category: Other
What the company is doing
The firm began to contact all US distributors on October 31, 2002, and all US sales representatives on November 1, 2002, by e-mail to initiate an examination of all Ascension MCP professional labeling in their stock, and request return of incorrect labeling. The firm additionally, initiated a program of telephone contact with all US distributors and sales representatives regarding this label examination request.
Recall details
- Recall number
- Z-0550-03
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- Oct 31, 2002
- Posted by the FDA
- Feb 8, 2003
- Recalling firm
- Ascension Orthopedics, Inc
- Quantity
- Currently being determined
- Product code
- ---
- FDA submissions
- P000057
- Distribution
- AL, AZ, NM, TX, FL, NJ, CA, IL, TN, MS, OH, KY, IN, MN, NY, OR, WA, CO, PA, UT, MO, OK, NC, VA, SC, MD, MA, CT, VT, ME, ID, LA, WI, NE
Product description
Ascension MCP, Prosthesis, Finger Joint, Metacarpophalangeal
Code information (models, lots, serial numbers)
Brochure intended for international distribution, Document: LC-04-107-011
Other devices under the same FDA submission
4 devices cleared under P000057 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- Ascension MCP Joint Replacement MCP-100-10P-WWSmith & Nephew, Inc. · Finger semi-constrained pyrolytic carbon uncemented prosthesis1 report
- Ascension MCP Joint Replacement MCP-100-20P-WWSmith & Nephew, Inc. · Finger semi-constrained pyrolytic carbon uncemented prosthesis1 report
- Ascension MCP Joint Replacement MCP-100-30D-WWSmith & Nephew, Inc. · Finger semi-constrained pyrolytic carbon uncemented prosthesis1 report
- Ascension® MCP MCP10030PWWAscension Orthopedics, Inc. · Finger Semi-Constrained Pyrolytic Carbon Uncemented Prosthesis1 report
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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