CLASS II Device recall · Reported 9 Mar 2022 · FDA Enforcement Report
The Darco¿ Locking Bone Plate System is designed recalled
Wright Medical Technology is recalling The Darco¿ Locking Bone Plate System is designed with rhombus (parallelogram) plates of. The recall was initiated on 9 Feb 2022 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0679-2022
- FDA event ID
- 89461
- Recalling firm
- Wright Medical Technology, Memphis, TN
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 9 Feb 2022
- FDA classified
- 25 Feb 2022
- Reported
- 9 Mar 2022
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 9 Feb 2022 | Recall initiated by company | |
| 25 Feb 2022 | Classified by FDA | +16 days |
| 9 Mar 2022 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Product was labelled with the incorrect manufacturing and distribution dates.
Product as listed by the FDA
The DARCO¿ Locking Bone Plate System is designed with rhombus (parallelogram) plates of biocompatible titanium. The plates use either 2.7mm or 3.5mm screws which intersect each other in pairs. The drill holes of the plates are aligned to assure the screws do not touch. The various plates model numbers differ from each other through among other things different curvatures, material strengths, lengths, number of plate holes and through different grades and bridge widths
Where it was distributed
International distribution in the countries of Japan and the United Kingdom.
Questions about this recall
Why was it recalled?
Product was labelled with the incorrect manufacturing and distribution dates.
Which lots are affected?
Model No. DCS2825126; Lot No. 11012187061566009
Where was it sold?
International distribution in the countries of Japan and the United Kingdom.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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