Stryker Howmedica Osteonics Restoration Hip system Cylindrical Distal Extension. Catalog Numbers 1212-3105, 1212-3115, 1212-3125, and 1212-3195. Sizes 12.5mm, 11.5mm, 19.5mm, and 10.5mm extensions. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Restoration Hip system Cylindrical Distal Extension. Catalog Numbers 1212-3105, 1212-3115, 1212-3125, and 1212-3195. Sizes 12.5mm, 11.5mm, 19.5mm, and 10.5mm extensions.
Brand
Stryker Howmedica Osteonics
Lot Codes / Batch Numbers
Lots: 96910501, 96949401, 96940901, 96950901.
Products Sold
Lots: 96910501; 96949401; 96940901; 96950901.
Stryker Howmedica Osteonics is recalling Restoration Hip system Cylindrical Distal Extension. Catalog Numbers 1212-3105, 1212-3115, 1212-312 due to The Cylindrical Distal Extensions were incorrectly coded and packaged.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
The Cylindrical Distal Extensions were incorrectly coded and packaged.
Recommended Action
Per FDA guidance
Stryker Orthopaedics sent product recall letters to the Branch/Agency involved on 2/10/2004 via FedEx. International distributor was sent notification on 2/10/2004.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026