FDA Medical Device Recalls (openFDA)
Nextremity Solutions: 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.
- Recall number
- Z-1501-2021
- Recalling firm
- Nextremity Solutions
- Product
- 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.
- Status
- Terminated
- Initiated
- 2021-03-26
- Posted
- not on file
- Terminated
- 2021-11-10
- Reason
- 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
- 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 Quality.PostMarket@zimmerbiomet.com. 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 CorporateQuality.PostMarket@zimmerbiomet.com.
- Quantity
- 123 units
- Distribution
- AL, AK, CA, IA,IL, IN, KY ,MD. MI, NJ, NY, OR, PA, SC, TX, VA
- Lot, serial or model codes
- Lot Number: 168B29619B UDI: 00817701020875
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- HWC
- Firm FEI
- 3009540749
- Firm city
- Warsaw
- Firm state
- IN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28