LCP Volar Distal Radius Plate Extra Articular 4H… recallZ-0489-2007 · Synthes · initiated Dec 5, 2006
Terminated All recalls posted in January 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 Synthes 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
Hole is malformed, leading to reduced construct strength.
FDA root cause category: Other
What the company is doing
All Sales Consultants were notified of the recall via teleconference on 12/5/06. The telephone script, part number and affected lot were communicated to the consultants during the teleconference. They were instructed to retrieve the affected product from the field.
Recall details
- Recall number
- Z-0489-2007
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- Dec 5, 2006
- Posted by the FDA
- Jan 11, 2007
- Recalling firm
- Synthes
- Quantity
- 11 units
- Product code
- HRS
- FDA submissions
- K012114
- Distribution
- The products were shipped to medical facilities in NJ, TN, LA, and KS. The products were also shipped to sales reps in PA, SC, and CA. The product was also shipped to Canada.
Product description
LCP Volar Distal Radius Plate Extra Articular 4H HD-RT-Long, LCP Volar Distal Radius Plate 2.4 mm, Catalog number 242.465
Code information (models, lots, serial numbers)
Catalog number 242.465, Lot number 5373486
Other devices under the same FDA submission
17 devices cleared under K012114 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- NA 212.818Synthes GmbH · PLATE, FIXATION, BONE9 reports
- NA 212.814Synthes GmbH · Screw, fixation, bone7 reports
- NA 412.814Synthes GmbH · Screw, fixation, bone6 reports
- NA 212.816Synthes GmbH · PLATE, FIXATION, BONE5 reports
- NA 412.818Synthes GmbH · Screw, fixation, bone5 reports
- NA 212.824Synthes GmbH · Screw, fixation, bone4 reports
- NA 212.826Synthes GmbH · PLATE, FIXATION, BONE4 reports
- NA 212.808Synthes GmbH · Screw, fixation, bone3 reports
- NA 212.812Synthes GmbH · PLATE, FIXATION, BONE3 reports
- NA 412.822Synthes GmbH · PLATE, FIXATION, BONE3 reports
- NA 212.806Synthes GmbH · PLATE, FIXATION, BONE1 report
- NA 412.816Synthes GmbH · 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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