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Nextra CH recallZ-0740-2022 · Nextremity Solutions · initiated Jan 13, 2022

Terminated

Is my device affected?

  1. 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.
  2. 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.
  3. 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

During insertion of the middle phalanx implant into bone, the driver may deform the implant locking mechanism and result in inadequate mating force between the middle and proximal phalanx implants, resulting in surgical delay, in-situ removal of the implant, use of alternative surgical approach, disassembly of the implants post-operatively, and revision

FDA root cause category: Device Design

What the company is doing

Nextremity Solution issued URGENT Medical Device Recall dated 1/13/22. Letter states reason for recall, health risk and action to take: 1. Review this notification and ensure that affected team members are aware of the contents. 2. Immediately locate and quarantine affected product (see Table 1 above) in your trunk stock inventory. 3. Immediately return all affected product from your trunk stock inventory. a. Complete Attachment 1- Medical Device Recall Return Response and send to [email protected] within three (3) days. This form must be returned even if you do not have affected products available to return in your territory. b. For each return, send a copy of Attachment 1 to [email protected]. c. Include a hardcopy of Attachment 1 in the package/box with your return shipment. d. Mark "RECALL" on the outside of the package/box. e. Ship to the address provided in Attachment 1- Medical Device Recall Return Response. 4. Retain a copy of your shipping documentation and Attachment 1- Medical Device Recall Return Response for your records in the event of a compliance audit of your facility. 5. If you have further questions or concerns after reviewing this notice, please call Nextremity Solutions at 574-376-2404 between 8:00 am and 5:00pm EST, Monday through Friday. Request to speak to a representative from quality and regulatory. Calls received outside of operating hours will receive a voicemail prompt. Alternatively, your questions may be emailed to [email protected].

Recall details

Recall number
Z-0740-2022
Status
Terminated
Initiated by the company
Jan 13, 2022
Recalling firm
Nextremity Solutions
Quantity
24 units
Product code
HWC
FDA submissions
K213530, K200840
Distribution
US Nationwide distribution in the states of AZ, IL, GA, LA, MD, NY, PA, TX, WA.

Product description

Nextra Cannulated Hammertoe Standard Instrument Kit-indicated for small bone reconstruction limited to inter-digital repair and fusion of the lesser toe SKU: CH-STD-KT

Code information (models, lots, serial numbers)

Lot Numbers: 1574701, 158961 UDI: 00817701026372

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Product lines

Other products in the same recall event

The FDA groups related products into one recall event (event 89588).

Sources and updates

How recalls are matched to devices · Editorial policy · Report an error on this page