InCore Lapidus recallZ-1501-2021 · Nextremity Solutions · initiated Mar 26, 2021
Terminated
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 Nextremity Solutions 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
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 category: Under Investigation by firm
What the company is doing
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].
Recall details
- Recall number
- Z-1501-2021
- Status
- Terminated
- Initiated by the company
- Mar 26, 2021
- Recalling firm
- Nextremity Solutions
- Quantity
- 123 units
- Product code
- HWC
- Distribution
- AL, AK, CA, IA,IL, IN, KY ,MD. MI, NJ, NY, OR, PA, SC, TX, VA
Product description
InCore Lapidus Disposable Kit 28mm Right, Part Number: IC-LAP-28R - Product Usage: Intended as a three-part construct intended for internal fixation for First Metatarsocuneiform arthrodesis.
Code information (models, lots, serial numbers)
Lot Number: 168B29619B UDI: 00817701020875
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- InCore Lapidus IC-LAP-28LMedartis Inc. · Screw, Fixation, Bone1 recall0 reports
Product lines
Other products in the same recall event
The FDA groups related products into one recall event (event 87665).
- Z-1500-2021 · TerminatedInCore 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 art…
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 16, 2026. Text above is shown as published by the FDA.
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