Hip Prosthesis as a component of Primaloc Cemented Hip… recallZ-0568-03 · Ortho Development Corporation · initiated Dec 26, 2002
Terminated All recalls posted in February 2003
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 Ortho Development Corporation 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
Cleaning agent residue from packaging material was adhering to implantable hip stems.
FDA root cause category: Other
What the company is doing
Consignees were notified on 12/26/2002 via telephone and e-mail.
Recall details
- Recall number
- Z-0568-03
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- Dec 26, 2002
- Posted by the FDA
- Feb 25, 2003
- Recalling firm
- Ortho Development Corporation
- Quantity
- 41
- FDA submissions
- K962448
- Distribution
- TX and Japan
Product description
Hip Prosthesis as a component of Primaloc Cemented Hip System.
Code information (models, lots, serial numbers)
Catalog # 114-0917, Lot # OD-18030-5, W003600, W003601, W003602. Catalog # 114-1017, Lot # OD-18563, OD-18563-1, OD-23190, OD-23191, OD-23221. Catalog # 114-1219, Lot # OD-23192, OD-23192-1, OD-23193, OD-23194. Catalog # 114-1421, Lot # OD-17306, OD-17412. Catalog # 114-1623, Lot # W0#003264, W003614.
Other devices under the same FDA submission
1 device cleared under K962448 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- Encompass Hip Stem 114-2010Ortho Development Corporation · Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented1 report
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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