6.5 Cancellous Bone Screw 25 mm recallZ-2007-2008 · Stryker Howmedica Osteonics Corp. · initiated Dec 20, 2005
Terminated All recalls posted in September 2008
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
The firm has been made aware that one lot of 6.5 Cancellous Bone Screws 25mm was packaged and labeled as 25 mm in length when it maybe 20 mm in length.
FDA root cause category: Labeling mix-ups
What the company is doing
The recalling firm sent notification letters and Product Accountability Forms via Fed Ex with return receipt on December 20, 2005. The notification letter described the problem, and asked customers to inventory and quarantine the affected product. Customers were told to return the affected product to Stryker. Contact Stryker at 1-201-831-5825 for assistance.
Recall details
- Recall number
- Z-2007-2008
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- Dec 20, 2005
- Posted by the FDA
- Sep 22, 2008
- Recalling firm
- Stryker Howmedica Osteonics Corp.
- Quantity
- 29 units
- Product code
- HWC
- FDA submissions
- K873251, K894124
- Distribution
- nationwide
Product description
6.5 Cancellous Bone Screw 25 mm; Responsible Firm on Label: Manufacturer, Howmedica Osteonics Corp., 325 Corporate Drive, Mahwah, NJ 07430 USA, A Subsidiary of Stryker Corp., Made in USA; Catalog Number: 2030-6525-1 The Omnifit bone screws are intended to augment the fixation of compatible acetabular cups.
Code information (models, lots, serial numbers)
Lot Code: 35323605
Other devices under the same FDA submission
7 devices cleared under K873251, K894124 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- Torx 2030-6525-1Howmedica Osteonics Corp. · Screw, fixation, bone27 reports
- Torx 2030-6530-1Howmedica Osteonics Corp. · Screw, fixation, bone18 reports
- Torx 2030-6535-1Howmedica Osteonics Corp. · Screw, fixation, bone13 reports
- Torx 2030-6520-1Howmedica Osteonics Corp. · Screw, fixation, bone9 reports
- Torx 2030-6540-1Howmedica Osteonics Corp. · Screw, fixation, bone9 reports
- Torx 2030-6516-1Howmedica Osteonics Corp. · Screw, fixation, bone7 reports
- Torx 2030-6545-1Howmedica Osteonics Corp. · Screw, fixation, bone1 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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