Z-2880-2018Class II

CoLink(TM) Lapidus Plate XP, +2 mm, Left, REF P40 ST265, QTY 1, In2Bones

Name: Z-2880-2018 CoLink(TM) Lapidus Plate XP, +2 mm, Left, REF P40 ST265, QTY 1, In2Bones
Creator: In2bones USA, LLC
Published: 2018-07-16
License: https://open.fda.gov/license/

In2bones USA, LLC / initiated 2018-07-16 / Terminated / root cause: manufacturing process

FDA source

In2bones USA, LLC began a recall of CoLink(TM) Lapidus Plate XP, +2 mm, Left, REF P40 ST265, QTY 1, In2Bones Product Usage: The In2Bones USA LLC, CoLink Plating System is indicated for... on 2018-07-16. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2880-2018
Classification: Class II
Status: Terminated
Initiated: 2018-07-16
Posted: 2018-08-21
Terminated: 2019-02-22
Recalling firm: In2bones USA, LLC
Product: CoLink(TM) Lapidus Plate XP, +2 mm, Left, REF P40 ST265, 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.
Product code: HWC Screw, Fixation, Bone
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.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: In2Bones sent a Medical Device Recall letter dated July 18, 2018 to affected customers (agents and hospitals). The letter identified the affected product, problem and actions to be taken. The Agent notice requested the consignee to inform and distribute the notice to all relevant person within the organization. The firm is seeking the return of the products The notice to the hospitals and healthcare professionals explained the problem and recommended that patients be monitored for any adverse events within the normal standard of practice. For questions contact Quality and Regulatory Affairs Team at 901-260-7931..
Quantity in commerce: 48 units
Distribution: Worldwide Distribution - US Nationwide and the countries of France
Product codes and lots: Lot Number 1704075

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2880-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2879-2018	Class II	Terminated	Voluntary: Firm initiated	2018-08-29	2018-08-21
Z-2880-2018	Class II	Terminated	Voluntary: Firm initiated	2018-08-29	2018-08-21

Product code HWC

K163293Class IIColink™ Plating SystemIn2bones USA, LLC / cleared 2017-05-05

China's FDA-registered implant bench is 151 establishments of 4,70415 SEP 2026 / by Medical Device Manufacturing

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)