Z-3246-2018Class II

Zimmer Natural Nail Tibial Nail - Yellow 8.3mm, Model Number 47249534008 Product Usage - The Zimmer Natural...

Name: Z-3246-2018 Zimmer Natural Nail Tibial Nail - Yellow 8.3mm, Model Number 47249534008 Product Usage - The Zimmer Natural...
Creator: Zimmer Biomet, Inc.
Published: 2018-07-30
License: https://open.fda.gov/license/

Zimmer GmbH / initiated 2018-07-30 / Terminated / root cause: labeling and UDI

FDA source

Zimmer Biomet, Inc. began a recall of Zimmer Natural Nail Tibial Nail - Yellow 8.3mm, Model Number 47249534008 Product Usage - The Zimmer Natural Nail System is intended for temporary fracture... on 2018-07-30. FDA classified it as Class II and gives the reason as "The item is labeled as an 8.3mm, but it is actually a 12 mm". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-3246-2018
Classification: Class II
Status: Terminated
Initiated: 2018-07-30
Posted: 2018-09-25
Terminated: 2019-10-24
Recalling firm: Zimmer GmbH
Product: 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.
Product code: HSB Rod, Fixation, Intramedullary And Accessories
Reason for recall: The item is labeled as an 8.3mm, but it is actually a 12 mm.
Root cause tag: labeling and UDI
FDA root cause: Mixed-up of materials/components
Action: 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
Quantity in commerce: 1 unit
Distribution: The product was not distributed in the United States. The product was distributed in the Netherlands.
Product codes and lots: UDI: (01)00889024097551(17)190228(10)61169228R, Lot 61169228R

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-3246-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-3246-2018	Class II	Terminated	Voluntary: Firm initiated	2018-10-03	2018-09-25

Product code HSB

K082770Class IIZimmer Natural Nail System Tibial NailZimmer, Inc. / cleared 2008-12-11

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)