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Natural Nail recallZ-3246-2018 · Zimmer Biomet, Inc. · initiated Jul 30, 2018

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 Zimmer 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

The item is labeled as an 8.3mm, but it is actually a 12 mm.

FDA root cause category: Mixed-up of materials/components

What the company is doing

On 7/30/18, Urgent Medical Device Recall notification letters were distributed to customers. Distributors were instructed to do the following: 1. Review this notification and ensure that affected team members are aware of the contents. 2. Immediately locate and quarantine affected product in your inventory. 3. Immediately return all affected product from your distributorship and from affected hospitals and surgeons within your territory. a. Complete Attachment 1 Inventory Return Certification Form and send to [email protected] within three (3) days. b. Request a Return Authorization Number through [email protected] for international returns c. For each return, send a copy of Attachment 1 to [email protected] d. Include a hardcopy of Attachment 1 in each carton of your return shipment for immediate processing. e. Mark RECALL on the outside of the returned cartons. 4. Retain a copy of your Inventory Return Certification and product return forms 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 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]. Risk Managers and Surgeons were asked to do the following: 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 Certificate of Acknowledgement an

Recall details

Recall number
Z-3246-2018
Status
Terminated
Initiated by the company
Jul 30, 2018
Recalling firm
Zimmer Biomet, Inc.
Quantity
1 unit
Product code
HSB
FDA submissions
K082770
Distribution
The product was not distributed in the United States. The product was distributed in the Netherlands.

Product description

Zimmer Natural Nail Tibial Nail - Yellow 8.3mm, Model Number 47249534008 Product Usage - The Zimmer Natural Nail System is intended for temporary fracture fixation and stabilization of the bone. Indications for the Tibial nails include the following in the tibia: Compound and simple shaft fractures Proximal, metaphyseal and distal shaft fractures Segmental fractures Comminuted fractures Fractures involving osteopenic and osteoporotic bone Pathological fractures Fractures with bone loss Pseudoarthrosis, non-union, mal-union and delayed union Periprosthetic fractures Surgically created defects such as osteotomies. Product Usage - The Zimmer Natural Nail System is intended for temporary fracture fixation and stabilization of the bone. Indications for the Tibial nails include the following in the tibia: Compound and simple shaft fractures Proximal, metaphyseal and distal shaft fractures Segmental fractures Comminuted fractures Fractures involving osteopenic and osteoporotic bone Pathological fractures Fractures with bone loss Pseudoarthrosis, non-union, mal-union and delayed union Periprosthetic fractures Surgically created defects such as osteotomies.

Code information (models, lots, serial numbers)

UDI: (01)00889024097551(17)190228(10)61169228R, Lot 61169228R

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

19 devices cleared under K082770 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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