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Modular Arthrodesis Nail recallZ-1036-2023 · Biomet, Inc. · initiated Nov 29, 2022

Open, Classified

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 Biomet, Inc. 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

Product missing the four small locking collar bolts resulting in extension of surgery to find a replacement

FDA root cause category: Process control

What the company is doing

****UPDATE***Phase II Zimmer Biomet issued Urgent Medical Device Recall Letter (Removal) on March 7, via FedEx to the Distributor and Risk Manager. Letter states health risk and action to take: Risk Manager Responsibilities: 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. If the product has been further distributed, provide your customers with the recall notice for hospitals and ensure documentation. 4. Complete Attachment 1 Certificate of Acknowledgement and send to [email protected]. This form shall be returned even if you do not have affected products at your facility. 5. Retain a copy of the acknowledgement form with your recall records in the event of a compliance audit of your facility s documentation. 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]. Zimmer Biomet is conducting the recall in a phased approach due to limited replacement products for the Modular Arthrodesis Nail Collar Assembly (PN: CP260602) and due to the ability to separately purchase the small locking collar bolts (PN: CP260603).Letter to Distributors via email on 11/29/22 states: Replacement Small Locking Collar Bolts (Part Number: CP260603) will be sent to your territory. Replacement orders were placed today, November 29, with overnight delivery to your main territory office (Phase 1) Once replacement devices are availab

Recall details

Recall number
Z-1036-2023
Status
Open, Classified
Initiated by the company
Nov 29, 2022
Posted by the FDA
Jan 27, 2023
Recalling firm
Biomet, Inc.
Quantity
2 units
Product code
HSB
FDA submissions
K042409
Distribution
US Nationwide distribution in the states of CA, KY, FL.

Product description

OSS Modular Arthrodesis Nail, 7 Degree Collar Assembly with Locking Bolts-For use in the replacement of segmental defects of long bone, including midshaft replacement, and arthrodesis of the knee Item Number: CP260602

Code information (models, lots, serial numbers)

UDI: (01)00880304082991(17)321103(10)136620 Lot Number: 136620

Devices named in this recall

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

Product lines

Other devices under the same FDA submission

5 devices cleared under K042409 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.

Sources and updates

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