Z-0775-2018Class II

979195 Loaner Kit for femoral intramedullary nail. Orthopedic instrument

Name: Z-0775-2018 979195 Loaner Kit for femoral intramedullary nail. Orthopedic instrument
Creator: Zimmer Biomet, Inc.
Published: 2017-09-13
License: https://open.fda.gov/license/

Zimmer GmbH / initiated 2017-09-13 / Terminated / root cause: design

FDA source

Zimmer Biomet, Inc. began a recall of 979195 Loaner Kit for femoral intramedullary nail. Orthopedic instrument on 2017-09-13. FDA classified it as Class II and gives the reason as "Fracture of the bolt connecting the insertion guide to the intramedullary nail during insertion of the femoral nail". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0775-2018
Classification: Class II
Status: Terminated
Initiated: 2017-09-13
Posted: 2018-02-27
Terminated: 2020-04-21
Recalling firm: Zimmer GmbH
Product: 979195 Loaner Kit for femoral intramedullary nail. Orthopedic instrument.
Product code: LXH Orthopedic Manual Surgical Instrument
Reason for recall: Fracture of the bolt connecting the insertion guide to the intramedullary nail during insertion of the femoral nail.
Root cause tag: design
FDA root cause: Device Design
Action: On September 13, 2017 an URGENT MEDICAL DEVICE RECALL REMOVAL was issued to customers requesting that they review inventory and quarantine affected product, which will be immediately returned to recalling firm. Also to notify any customers who may have received product. Questions or concerns can be directed to Customer Service at 574-371-3071
Quantity in commerce: 337 total
Distribution: Distribution includes US Nationwide.
Product codes and lots: Finished Lot order: M370490 M354450 M321540 M975460 M639280 M426760 M629950 M629930 M073530 M073540 M073550 M073560 M073570 M073580 M073590 M073600 M073610 M627490 M656470 M656580 M656590 M656600 M656610 M656620 M656640 M656660 M966880 M967050 M967060 M967070 M980260 M980270 M508490 M508410 M508500 M508450 M508480 M508520 M508470 M508510 M508460

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0775-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0773-2018	Class II	Terminated	Voluntary: Firm initiated	2018-03-07	2018-02-27
Z-0774-2018	Class II	Terminated	Voluntary: Firm initiated	2018-03-07	2018-02-27
Z-0775-2018	Class II	Terminated	Voluntary: Firm initiated	2018-03-07	2018-02-27

Product code LXH

The FDA recall record names no cleared device, and no clearance has been matched to it.

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 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)