Foundation Hip System Bipolar Modular, Size 44mm OD recallZ-0086-2008 · Encore Medical, Lp · initiated Aug 2, 2007
Terminated All recalls posted in November 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
Device mislabeled. Hip prosthesis components validated for 5 years were labeled as having a 6 year expiration date.
FDA root cause category: Packaging change control
What the company is doing
Firm notified consignees of recall via phone, e-mail and overnight letters beginning on 08/02/07. Consignees asked to return devices for a properly labeled replacement.
Recall details
- Recall number
- Z-0086-2008
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- Aug 2, 2007
- Posted by the FDA
- Nov 7, 2007
- Recalling firm
- Encore Medical, Lp
- Quantity
- 776 units.
- Product code
- KWY
- FDA submissions
- K953510
- Distribution
- Worldwide, including USA, Greece, Japan, and Saudi Arabia.
Product description
Foundation Hip System Bipolar Modular, Size 44mm OD; Cat. #412-01-044; Sterile; assembly required by physician prior to implant; manufactured by Encore Medical, L.P., Austin, TX 78758.
Code information (models, lots, serial numbers)
Show the full code information (1k characters)
Lot #: 640791, 640801, 640811, 677101, 677111, 678581, 678591, 678601, 678611, 678621, 679611, 679621, 693841, 693851, 693861, 695121, 695861, 697851, 697861, 698771, 730141, 730221, 731481, 003612, 003622, 003632, 003642, 208672, 735781, 736431, 736441, 736451, 736461, 736751, 737391, 738431, 738891, 738911, 770081, 770191, 772371, 776721, 778421, 780161, 783931, 788381, 788391, 794401, 795481, 795491, 812181, 812191, 812201, 812211, 813511, 817551, 817561, 833181, 833191, 834981, 834991, 837691, 837791, 842321, 842331, 847351, 847361, 847391, 847401, 854341, 854381, 854391, 854401, 854411, 857691, 857701, 874991, 875001, 878331, 878351, 878531, 878541, 882611, 882621, 882631, 891271, 891281, 891301, 893631, 893641, 905571, 905581, 907081, 907091, 907101, 907111, 925761, 925771, 932731, 932741, 938211, 938221, 949431, 949441, 951081, 964251, 964261, 964271, 964281, 964291, 964301, 964311 and 421494A.
Other devices under the same FDA submission
19 devices cleared under K953510 — 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 412-02-046Encore Medical, L.P. · Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented14 reports
- DJO SURGICAL 412-02-048Encore Medical, L.P. · Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented14 reports
- DJO SURGICAL 412-02-045Encore Medical, L.P. · Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented12 reports
- DJO SURGICAL 412-02-052Encore Medical, L.P. · Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented11 reports
- DJO SURGICAL 412-02-044Encore Medical, L.P. · Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented8 reports
- DJO SURGICAL 412-02-047Encore Medical, L.P. · Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented8 reports
- DJO SURGICAL 412-02-050Encore Medical, L.P. · Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented6 reports
- DJO SURGICAL 412-02-042Encore Medical, L.P. · Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented5 reports
- DJO SURGICAL 412-02-054Encore Medical, L.P. · Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented5 reports
- DJO SURGICAL 412-02-049Encore Medical, L.P. · Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented4 reports
- DJO SURGICAL 412-02-051Encore Medical, L.P. · Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented4 reports
- DJO SURGICAL 412-02-056Encore Medical, L.P. · Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented4 reports
Other products in the same recall event
The FDA groups related products into one recall event (event 44788).
- Z-0082-2008 · TerminatedFoundation Hip System Bipolar Modular, Size 40mm OD; Cat. #412-01-040; Sterile; assembly required by physician prior to implant; manufactured by Encore Medical, L.P., Austin, TX 7…
- Z-0083-2008 · TerminatedFoundation Hip System Bipolar Modular, Size 41mm OD; Cat. #412-01-041; Sterile; assembly required by physician prior to implant; manufactured by Encore Medical, L.P., Austin, TX 7…
- Z-0084-2008 · TerminatedFoundation Hip System Bipolar Modular, Size 42mm OD; Cat. #412-01-042; Sterile; assembly required by physician prior to implant; manufactured by Encore Medical, L.P., Austin, TX 7…
- Z-0085-2008 · TerminatedFoundation Hip System Bipolar Modular, Size 43mm OD; Cat. #412-01-043; Sterile; assembly required by physician prior to implant; manufactured by Encore Medical, L.P., Austin, TX 7…
- Z-0087-2008 · TerminatedFoundation Hip System Bipolar Modular, Size 45mm OD; Cat. #412-01-045; Sterile; assembly required by physician prior to implant; manufactured by Encore Medical, L.P., Austin, TX 7…
- Z-0088-2008 · TerminatedFoundation Hip System Bipolar Modular, Size 46mm OD; Cat. #412-01-046; Sterile; assembly required by physician prior to implant; manufactured by Encore Medical, L.P., Austin, TX 7…
- Z-0089-2008 · TerminatedFoundation Hip System Bipolar Modular, Size 47mm OD; Cat. #412-01-047; Sterile; assembly required by physician prior to implant; manufactured by Encore Medical, L.P., Austin, TX 7…
- Z-0090-2008 · TerminatedFoundation Hip System Bipolar Modular, Size 48mm OD; Cat. #412-01-048; Sterile; assembly required by physician prior to implant; manufactured by Encore Medical, L.P., Austin, TX 7…
- Z-0091-2008 · TerminatedFoundation Hip System Bipolar Modular, Size 49mm OD; Cat. #412-01-049; Sterile; assembly required by physician prior to implant; manufactured by Encore Medical, L.P., Austin, TX 7…
- Z-0092-2008 · TerminatedFoundation Hip System Bipolar Modular, Size 50mm OD; Cat. #412-01-050; Sterile; assembly required by physician prior to implant; manufactured by Encore Medical, L.P., Austin, TX 7…
- Z-0093-2008 · TerminatedFoundation Hip System Bipolar Modular, Size 51mm OD; Cat. #412-01-051; Sterile; assembly required by physician prior to implant; manufactured by Encore Medical, L.P., Austin, TX 7…
- Z-0094-2008 · TerminatedFoundation Hip System Bipolar Modular, Size 52mm OD; Cat. #412-01-052; Sterile; assembly required by physician prior to implant; manufactured by Encore Medical, L.P., Austin, TX 7…
- Z-0095-2008 · TerminatedFoundation Hip System Bipolar Modular, Size 53mm OD; Cat. #412-01-053; Sterile; assembly required by physician prior to implant; manufactured by Encore Medical, L.P., Austin, TX 7…
- Z-0096-2008 · TerminatedFoundation Hip System Bipolar Modular, Size 54mm OD; Cat. #412-01-054; Sterile; assembly required by physician prior to implant; manufactured by Encore Medical, L.P., Austin, TX 7…
- Z-0097-2008 · TerminatedFoundation Hip System Bipolar Modular, Size 56mm OD; Cat. #412-01-056; Sterile; assembly required by physician prior to implant; manufactured by Encore Medical, L.P., Austin, TX 7…
- Z-0098-2008 · TerminatedFoundation Hip System Bipolar Modular, Size 58mm OD; Cat. #412-01-058; Sterile; assembly required by physician prior to implant; manufactured by Encore Medical, L.P., Austin, TX 7…
- Z-0099-2008 · TerminatedFoundation Hip System Bipolar Modular, Size 60mm OD; Cat. #412-01-060; Sterile; assembly required by physician prior to implant; manufactured by Encore Medical, L.P., Austin, TX 7…
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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