Recall archive / FDA device enforcement
Comprehensive Shoulder Stem, Comprehensive Micro Stem, Comprehensive Mini Stem; uncemented shoulder prosthesis, Model... — FDA record Z-1403-2025
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Mar 3, 2025. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- Comprehensive Shoulder Stem, Comprehensive Micro Stem, Comprehensive Mini Stem; uncemented shoulder prosthesis, Model Nos. 113605, 113606, 113607, 113627
- Reason
- Five complaints received where surgeon was unable to remove and/or connect the inserter with the stem during surgery due to excess material remaining within the taper. Issue may lead to clinically significant extension of surgery to find a replacement.
- Classification
- Class II
- Recalling firm
- ZIMMER ORTHOPEDICS MANFACTURING LIMITED-GALWAY
- Quantity
- 90 US; 136 OUS
- Agency-reported status
- Ongoing
- Source record identifier
- Z-1403-2025
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | Item No. 113605, UDI-DI 00887868267550 Lots 66173214, 66173215; Item No. 113606, UDI-DI 00887868267567 Lots 66173216, 66173218, 66173219; Item No. 113607, UDI-DI 00887868267574 Lots 66173220, 66173221; Item No. 113627, UDI-DI 00887868267741 Lots 65901697, 65909480, 65915809 |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
US distribution nationwide. International distribution to Dominican Republic, Canada, India, Australia, Japan, EMEA, Korea, Taiwan, and Hong Kong.
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
- Alaska
- Alabama
- Arkansas
- Arizona
- California
- Colorado
- Connecticut
- Delaware
- Florida
- Georgia
- Hawaii
- Iowa
- Idaho
- Illinois
- Indiana
- Kansas
- Kentucky
- Louisiana
- Massachusetts
- Maryland
- Maine
- Michigan
- Minnesota
- Missouri
- Mississippi
- Montana
- North Carolina
- North Dakota
- Nebraska
- New Hampshire
- New Jersey
- New Mexico
- Nevada
- New York
- Ohio
- Oklahoma
- Oregon
- Pennsylvania
- Rhode Island
- South Carolina
- South Dakota
- Tennessee
- Texas
- Utah
- Virginia
- Vermont
- Washington
- Wisconsin
- West Virginia
- Wyoming
Dates in the source
- Report date
- Mar 26, 2025
- Recall initiation date
- Mar 3, 2025
- Center classification date
- Mar 20, 2025
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.