Z-1500-2021Class II

InCore Lapidus Disposable Kit 28mm Left, Part Number: IC-LAP-28L -

Name: Z-1500-2021 InCore Lapidus Disposable Kit 28mm Left, Part Number: IC-LAP-28L -
Creator: Nextremity Solutions
Published: 2021-03-26
License: https://open.fda.gov/license/

Medartis AG / initiated 2021-03-26 / Terminated

FDA source

Nextremity Solutions began a recall of InCore Lapidus Disposable Kit 28mm Left, Part Number: IC-LAP-28L - Product Usage: Intended as a three-part construct intended for internal fixation for First... on 2021-03-26. FDA classified it as Class II and gives the reason as "Product could potentially contain an undersized inner diameter of the 40mm drill bushing which result in not allowing the drill bit to pass through the drill bushing, causing inability of surgeon to complete surgical...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1500-2021
Classification: Class II
Status: Terminated
Initiated: 2021-03-26
Posted: 2021-04-27
Terminated: 2021-11-10
Recalling firm: Medartis AG
Product: InCore Lapidus Disposable Kit 28mm Left, Part Number: IC-LAP-28L - Product Usage: Intended as a three-part construct intended for internal fixation for First Metatarsocuneiform arthrodesis.
Product code: HWC Screw, Fixation, Bone
Reason for recall: Product could potentially contain an undersized inner diameter of the 40mm drill bushing which result in not allowing the drill bit to pass through the drill bushing, causing inability of surgeon to complete surgical procedure as intended
FDA root cause: Under Investigation by firm
Action: Nextremity Solutions issued Urgent Medical Device Recall Letter to Distributors and Risk Managers on March 26,2021 stating reason for recall, health risk and action to take: 1. Review this notification and ensure that affected personnel are aware of the contents. 2. If you have affected product at your facility, assist your Zimmer Biomet sales representative and quarantine all affected product. Your Zimmer Biomet sales representative will remove the affected product from your facility. 3. Complete Attachment 1 - Medical Device Recall Return Response and send to Corporate [email protected]. This form will be returned even if you do not have affected products at your facility. 4. Retain a copy of the acknowledgement form with your recall records in the event of a compliance audit facility's documentation. 5. If you have further questions or concerns after reviewing this notice, please call customer service at 574- 371-3071 between 8:00 am and 5:00pm EST, Monday through Friday. Calls received outside of call center operating hours will receive a voicemail prompt or be transferred to an on-call representative in the event of an emergency. Alternatively, your questions may be emailed to [email protected].
Quantity in commerce: 111 units
Distribution: AL, AK, CA, IA,IL, IN, KY ,MD. MI, NJ, NY, OR, PA, SC, TX, VA
Product codes and lots: Lot Number: 168B29619A UDI: 00817701020868

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1500-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1500-2021	Class II	Terminated	Voluntary: Firm initiated	2021-05-05	2021-04-27
Z-1501-2021	Class II	Terminated	Voluntary: Firm initiated	2021-05-05	2021-04-27

Product code HWC

The FDA recall record names no cleared device, and no clearance has been matched to it.

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)