FDA Medical Device Recalls (openFDA)
Ascension Orthopedics, Inc: Ascension MCP, Prosthesis, Finger Joint, Metacarpophalangeal
- Recall number
- Z-0550-03
- Recalling firm
- Ascension Orthopedics, Inc
- Product
- Ascension MCP, Prosthesis, Finger Joint, Metacarpophalangeal
- Status
- Terminated
- Initiated
- 2002-10-31
- Posted
- 2003-02-08
- Terminated
- 2003-12-03
- Reason
- Literature approved for international distribution only was distributed domestically.
- Root cause
- Other
- Action
- 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.
- Quantity
- Currently being determined
- 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
- Lot, serial or model codes
- Brochure intended for international distribution, Document: LC-04-107-011
- 510(k) numbers
- not on file
- PMA numbers
- ["P000057"]
- Product code
- ---
- Firm FEI
- 3002788818
- Firm city
- Austin
- Firm state
- TX
- 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