ALFA II Modular Femoral Left Modular Stem Porous Coated (Bowed); Size 6 Left; Length: 250mm; Distal Diameter: 18.0mm; Catalog #652-06-180L; component of the ENCORE Hip System; Single Use, Sterile; distributed by Encore Medical, L.P., Austin, TX 78758. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
ALFA II Modular Femoral Left Modular Stem Porous Coated (Bowed); Size 6 Left; Length: 250mm; Distal Diameter: 18.0mm; Catalog #652-06-180L; component of the ENCORE Hip System; Single Use, Sterile; distributed by Encore Medical, L.P., Austin, TX 78758.
Lot Codes / Batch Numbers
Lot #Y131E and 2475.
Products Sold
Lot #Y131E and 2475.
A medical device manufacturer is recalling ALFA II Modular Femoral Left Modular Stem Porous Coated (Bowed); Size 6 Left; Length: 250mm; Distal due to Sterility/Package Integrity: Device packaging may potentially be unable to ensure sterility when exposed to shipping conditions.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Sterility/Package Integrity: Device packaging may potentially be unable to ensure sterility when exposed to shipping conditions.
Recommended Action
Per FDA guidance
Urgent Device Recall Notification letters distributed to consignees on 04/14/07. Consignees requested to return product to Encore Medical, L.P.
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 noticeDistribution
As reported by FDA
CT, IN, KS, MO
Page updated: Jan 10, 2026