Trident 10 degrees X3 Insert 36 mm ID recallZ-2810-2015 · Stryker Howmedica Osteonics Corp. · initiated Jun 25, 2015
Class II Terminated All recalls posted in September 2015
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 Stryker Howmedica Osteonics Corp. 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
it was discovered that item 623-10-36I Lot 3Y0KHP, although meeting all device specifications, was determined to be unacceptable due to a documentation issue. However the parts were inadvertently shipped to the field.
FDA root cause category: Nonconforming Material/Component
What the company is doing
Stryker Orthopaedics notified their branches via email on 6/25/2015. Notification letters and Product Accountability Forms were mailed to Stryker Branches/Agencies on 817/2015 and hospital risk management on 8/18/2015.
Recall details
- Recall number
- Z-2810-2015
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- Jun 25, 2015
- Posted by the FDA
- Sep 23, 2015
- Recalling firm
- Stryker Howmedica Osteonics Corp.
- Quantity
- 16 units
- Product code
- LPH
- FDA submissions
- K033716
- Distribution
- Distributed in WI.
Product description
Trident 10 degrees X3 Insert 36 mm ID Catalog #623-10-36I Hip implant component
Code information (models, lots, serial numbers)
Lot Code 3Y0KHP
Other devices under the same FDA submission
8 devices cleared under K033716 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- Trident 623-00-36EHowmedica Osteonics Corp. · Prosthesis, hip, semi-constrained, metal/polymer, uncemented112 reports
- Trident 643-00-36EHowmedica Osteonics Corp. · Prosthesis, hip, semi-constrained, metal/polymer, cemented8 reports
- Trident 643-00-36FHowmedica Osteonics Corp. · Prosthesis, hip, semi-constrained, uncemented, metal/polymer, non-porous, calicum-phosphate8 reports
- Trident 663-00-32DHowmedica Osteonics Corp. · Prosthesis, hip, semi-constrained, metal/polymer, cemented4 reports
- Trident 663-00-36EHowmedica Osteonics Corp. · Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented3 reports
- Trident 623-10-28CHowmedica Osteonics Corp. · Prosthesis, hip, semi-constrained, metal/polymer, uncemented3 reports
- Trident 663-00-36GHowmedica Osteonics Corp. · PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED2 reports
- Trident 663-00-36FHowmedica Osteonics Corp. · Prosthesis, hip, semi-constrained, uncemented, metal/polymer, non-porous, calicum-phosphate1 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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