ALFA II Modular Femoral Left Modular Stem Porous Coated… recallZ-1065-2007 · Encore Medical, Lp · initiated Apr 12, 2007
Terminated All recalls posted in July 2007
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Encore Medical, Lp or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Sterility/Package Integrity: Device packaging may potentially be unable to ensure sterility when exposed to shipping conditions.
FDA root cause category: Other
What the company is doing
Urgent Device Recall Notification letters distributed to consignees on 04/14/07. Consignees requested to return product to Encore Medical, L.P.
Recall details
- Recall number
- Z-1065-2007
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- Apr 12, 2007
- Posted by the FDA
- Jul 23, 2007
- Recalling firm
- Encore Medical, Lp
- Quantity
- 2 units.
- Product code
- JDI
- FDA submissions
- K000817
- Distribution
- Product distributed to surgical centers in CT, KS and MO.
Product description
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.
Code information (models, lots, serial numbers)
Lot #Y131E and 2475.
Other devices under the same FDA submission
2 devices cleared under K000817 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- DJO SURGICAL 410-32-108Encore Medical, L.P. · Prosthesis, hip, semi-constrained, metal/polymer, cemented3 reports
- DJO SURGICAL 410-35-108Encore Medical, L.P. · Prosthesis, hip, semi-constrained, metal/polymer, cemented1 report
Other products in the same recall event
The FDA groups related products into one recall event (event 37881).
- Z-1063-2007 · TerminatedALFA II Modular Femoral Revision Stem Porous Coated; Size 6; Length: 200mm; Diameter:18.0mm; Catalog #651-06-180; component of the ENCORE Hip System; Single Use, Sterile; distribut…
- Z-1064-2007 · TerminatedALFA II Modular Femoral Stem Pourous Coated; Size 7; Length 200mm; Distal Diameter: 19.5mm; Catalog #651-07-195; component of the ENCORE Hip System; Single Use, Sterile; distribut…
- Z-1066-2007 · TerminatedALFA II Modular Femoral Right Modular Stem Porous Coated (Bowed); Size 6 Right; Length: 250mm; Distal Diameter: 18.0mm; Catalog #652-06-180R; component of the ENCORE Hip System; Si…
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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