CLASS II Device recall · Reported 29 Aug 2018 · FDA Enforcement Report
CoLink(TM) Lapidus Plate XP, +, Right recalled by In2bones USA
In2bones USA is recalling CoLink(TM) Lapidus Plate XP, +, Right, distributed nationwide in the US. The recall was initiated on 16 Jul 2018 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-2879-2018
- FDA event ID
- 80618
- Recalling firm
- In2bones USA, Memphis, TN
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 16 Jul 2018
- FDA classified
- 21 Aug 2018
- Reported
- 29 Aug 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 16 Jul 2018 | Recall initiated by company | |
| 21 Aug 2018 | Classified by FDA | +36 days |
| 29 Aug 2018 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
CoLink(TM) Lapidus Plate +2mm Right and Left, were laser marked incorrectly. In these lots, right plates were laser marked as left plates and the left plates were laser marked as right plates.
Product as listed by the FDA
CoLink(TM) Lapidus Plate XP, +2 mm, Right, REF P40 ST165, QTY 1, In2Bones Product Usage: The In2Bones USA LLC, CoLink¿ Plating System is indicated for stabilization and fixation of fractures, revision procedures, joint fusion, osteotomies and reconstruction of the small bones in the hand, wrist, foot and ankle in both pediatric and adult patients.
Where it was distributed
Worldwide Distribution - US Nationwide and the countries of France
Questions about this recall
Why was it recalled?
CoLink(TM) Lapidus Plate +2mm Right and Left, were laser marked incorrectly. In these lots, right plates were laser marked as left plates and the left plates were laser marked as right plates.
Which lots are affected?
Lot Number 1704073
Where was it sold?
Worldwide Distribution - US Nationwide and the countries of France
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.
Other products in this recall event
1 other product · FDA event 80618| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | CoLink(TM) Lapidus Plate XP, +, Left recalled by In2bones USA | In2bones USA | Other | Nationwide |
More recalls from In2bones USA
All 5| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | NeoSpan¿ SuperElastic Compression Staple w/Instruments recalled | In2bones USA | Foreign Material | 25 states |
| Device | CLASS II | CoLink Bone Graft Harvester, Sterile, Disposable recalled | In2bones USA | Device Malfunction | Nationwide |
| Device | CLASS II | NeoSpan SuperElastic Compression Staple w/Instruments, Size 10x10x10 recalled | In2bones USA | Other | 11 states |
| Device | CLASS II | CoLink(TM) Lapidus Plate XP, +, Left recalled by In2bones USA | In2bones USA | Other | Nationwide |
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