Recalls / —
—#41742
Product
Meridian PA Femoral Stem
- FDA product code
- MAY — Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous Cemented, Osteophilic Finish
- Device class
- Class 2
- Medical specialty
- Orthopedic
- 510(k) numbers
- K940307
- Affected lot / code info
- Catalog No --Description -- # of Lots: 6261-0-001, Meridian PA Hip Stem #00/9, 25 lots; 6261-0-002, Meridian PA Hip Stem #00/10, 26 lots; 6261-0-003, Meridian PA Hip Stem #1/11MM, 107 lots; 6261-0-004, Meridian PA Hip Stem #2/10MM, 16 lots; 6261-0-005, Meridian PA Hip Stem #2/12MM, 109 lots; 6261-0-006, Meridian PA Hip Stem #3/11MM 150 lots; 6261-0-007, Meridian PA Hip Stem #3/13MM, 256 lots; 6261-0-008, Meridian PA Hip Stem #4/12MM, 115 lots; 6261-0-009, Meridian PA Hip Stem #4/14MM, 194 lots; 6261-0-010, Meridian PA Hip Stem #5/13MM, 139 lots; 6261-0-011, Meridian PA Hip Stem #5/15MM, 104 lots; 6261-0-012, Meridian PA Hip Stem #6/14MM, 96 lots; 6261-0-013, Meridian PA Hip Stem, #6/16MM, 73 lots; 6261-0-014, Meridian PA Hip Stem, #7/15MM, 21 lots; 6261-0-015, Meridian PA Hip Stem, #7/17MM, 25 lots; 6261-0-016, Meridian PA Hip Stem, #8/16, 16 lots; 6261-0-017, Meridian PA Hip Stem, #8/18, 15 lots;
Why it was recalled
The V40 femoral head may not properly engage on the referenced V40 cobal chrome femoral hip stems.
Root cause (FDA determination)
Other
Action the firm took
A urgent product recall notification was sent out to all hospitals on August 24, 2005, branches and agencies by first class mail. The action is limited only to that product manufactured in the Stryker Ireland facility for the product families indicated.
Recalling firm
- Firm
- Stryker Howmedica Osteonics Corp.
- Address
- 325 Corporate Dr, Mahwah, New Jersey 07430-2002
Distribution
- Distribution pattern
- nationwide
Timeline
- Recall initiated
- 2005-08-24
- Posted by FDA
- 2005-11-01
- Terminated
- 2006-04-05
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #41742. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.