Z-0425-2018Class II

Affixus Hip Fracture Nail, LH 125 DEG 11MM X 360MM

Name: Z-0425-2018 Affixus Hip Fracture Nail, LH 125 DEG 11MM X 360MM
Creator: Zimmer Biomet, Inc.
Published: 2017-08-07
License: https://open.fda.gov/license/

Zimmer GmbH / initiated 2017-08-07 / Terminated

FDA source

Zimmer Biomet, Inc. began a recall of Affixus Hip Fracture Nail, LH 125 DEG 11MM X 360MM on 2017-08-07. FDA classified it as Class II and gives the reason as "During the rework process for the April 17, 2017, field action, it was detected that the set screw and sleeve assembly which are designed to have an interference fit, were no longer in the installed location. This could...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0425-2018
Classification: Class II
Status: Terminated
Initiated: 2017-08-07
Posted: 2018-01-29
Terminated: 2019-03-29
Recalling firm: Zimmer GmbH
Product: Affixus Hip Fracture Nail, LH 125 DEG 11MM X 360MM
Product code: HSB Rod, Fixation, Intramedullary And Accessories
Reason for recall: During the rework process for the April 17, 2017, field action, it was detected that the set screw and sleeve assembly which are designed to have an interference fit, were no longer in the installed location. This could prevent the product assembly with the mating screw and targeting jig.
FDA root cause: Process change control
Action: Customers were notified via FedEx and/or email on approximately 08/07/2017. Instructions include ensure appropriate personnel are notified of the recall, locate and quarantine affected product in inventory, complete and return the Certification of Acknowledgement, return all affected product, and provide the names of hospitals or customers that would have received this product if further distributed.
Quantity in commerce: 638 units
Distribution: US nationwide distribution. Also Portugal and the Netherlands.
Product codes and lots: Item No. 814411360; Lot No. 935900; Exp. Date 06/15/2027, UDI (01)00887868038488 (17)270615 (10)935900

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0425-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0420-2018	Class II	Terminated	Voluntary: Firm initiated	2018-02-07	2018-01-29
Z-0421-2018	Class II	Terminated	Voluntary: Firm initiated	2018-02-07	2018-01-29
Z-0422-2018	Class II	Terminated	Voluntary: Firm initiated	2018-02-07	2018-01-29
Z-0423-2018	Class II	Terminated	Voluntary: Firm initiated	2018-02-07	2018-01-29
Z-0424-2018	Class II	Terminated	Voluntary: Firm initiated	2018-02-07	2018-01-29
Z-0425-2018	Class II	Terminated	Voluntary: Firm initiated	2018-02-07	2018-01-29
Z-0426-2018	Class II	Terminated	Voluntary: Firm initiated	2018-02-07	2018-01-29
Z-0427-2018	Class II	Terminated	Voluntary: Firm initiated	2018-02-07	2018-01-29
Z-0428-2018	Class II	Terminated	Voluntary: Firm initiated	2018-02-07	2018-01-29
Z-0429-2018	Class II	Terminated	Voluntary: Firm initiated	2018-02-07	2018-01-29
Z-0430-2018	Class II	Terminated	Voluntary: Firm initiated	2018-02-07	2018-01-29
Z-0431-2018	Class II	Terminated	Voluntary: Firm initiated	2018-02-07	2018-01-29
Z-0432-2018	Class II	Terminated	Voluntary: Firm initiated	2018-02-07	2018-01-29
Z-0433-2018	Class II	Terminated	Voluntary: Firm initiated	2018-02-07	2018-01-29
Z-0434-2018	Class II	Terminated	Voluntary: Firm initiated	2018-02-07	2018-01-29
Z-0435-2018	Class II	Terminated	Voluntary: Firm initiated	2018-02-07	2018-01-29
Z-0436-2018	Class II	Terminated	Voluntary: Firm initiated	2018-02-07	2018-01-29
Z-0437-2018	Class II	Terminated	Voluntary: Firm initiated	2018-02-07	2018-01-29
Z-0438-2018	Class II	Terminated	Voluntary: Firm initiated	2018-02-07	2018-01-29
Z-0439-2018	Class II	Terminated	Voluntary: Firm initiated	2018-02-07	2018-01-29
Z-0440-2018	Class II	Terminated	Voluntary: Firm initiated	2018-02-07	2018-01-29
Z-0441-2018	Class II	Terminated	Voluntary: Firm initiated	2018-02-07	2018-01-29
Z-0442-2018	Class II	Terminated	Voluntary: Firm initiated	2018-02-07	2018-01-29
Z-0443-2018	Class II	Terminated	Voluntary: Firm initiated	2018-02-07	2018-01-29
Z-0444-2018	Class II	Terminated	Voluntary: Firm initiated	2018-02-07	2018-01-29
Z-0445-2018	Class II	Terminated	Voluntary: Firm initiated	2018-02-07	2018-01-29
Z-0446-2018	Class II	Terminated	Voluntary: Firm initiated	2018-02-07	2018-01-29
Z-0447-2018	Class II	Terminated	Voluntary: Firm initiated	2018-02-07	2018-01-29
Z-0448-2018	Class II	Terminated	Voluntary: Firm initiated	2018-02-07	2018-01-29
Z-0449-2018	Class II	Terminated	Voluntary: Firm initiated	2018-02-07	2018-01-29
Z-0450-2018	Class II	Terminated	Voluntary: Firm initiated	2018-02-07	2018-01-29
Z-0451-2018	Class II	Terminated	Voluntary: Firm initiated	2018-02-07	2018-01-29
Z-0452-2018	Class II	Terminated	Voluntary: Firm initiated	2018-02-07	2018-01-29
Z-0453-2018	Class II	Terminated	Voluntary: Firm initiated	2018-02-07	2018-01-29
Z-0454-2018	Class II	Terminated	Voluntary: Firm initiated	2018-02-07	2018-01-29
Z-0455-2018	Class II	Terminated	Voluntary: Firm initiated	2018-02-07	2018-01-29
Z-0456-2018	Class II	Terminated	Voluntary: Firm initiated	2018-02-07	2018-01-29
Z-0457-2018	Class II	Terminated	Voluntary: Firm initiated	2018-02-07	2018-01-29
Z-0458-2018	Class II	Terminated	Voluntary: Firm initiated	2018-02-07	2018-01-29
Z-0459-2018	Class II	Terminated	Voluntary: Firm initiated	2018-02-07	2018-01-29
Z-0460-2018	Class II	Terminated	Voluntary: Firm initiated	2018-02-07	2018-01-29
Z-0461-2018	Class II	Terminated	Voluntary: Firm initiated	2018-02-07	2018-01-29
Z-0462-2018	Class II	Terminated	Voluntary: Firm initiated	2018-02-07	2018-01-29
Z-0463-2018	Class II	Terminated	Voluntary: Firm initiated	2018-02-07	2018-01-29
Z-0464-2018	Class II	Terminated	Voluntary: Firm initiated	2018-02-07	2018-01-29
Z-0465-2018	Class II	Terminated	Voluntary: Firm initiated	2018-02-07	2018-01-29
Z-0466-2018	Class II	Terminated	Voluntary: Firm initiated	2018-02-07	2018-01-29
Z-0467-2018	Class II	Terminated	Voluntary: Firm initiated	2018-02-07	2018-01-29
Z-0468-2018	Class II	Terminated	Voluntary: Firm initiated	2018-02-07	2018-01-29
Z-0469-2018	Class II	Terminated	Voluntary: Firm initiated	2018-02-07	2018-01-29
Z-0470-2018	Class II	Terminated	Voluntary: Firm initiated	2018-02-07	2018-01-29
Z-0471-2018	Class II	Terminated	Voluntary: Firm initiated	2018-02-07	2018-01-29
Z-0472-2018	Class II	Terminated	Voluntary: Firm initiated	2018-02-07	2018-01-29
Z-0473-2018	Class II	Terminated	Voluntary: Firm initiated	2018-02-07	2018-01-29
Z-0474-2018	Class II	Terminated	Voluntary: Firm initiated	2018-02-07	2018-01-29
Z-0475-2018	Class II	Terminated	Voluntary: Firm initiated	2018-02-07	2018-01-29
Z-0476-2018	Class II	Terminated	Voluntary: Firm initiated	2018-02-07	2018-01-29
Z-0477-2018	Class II	Terminated	Voluntary: Firm initiated	2018-02-07	2018-01-29
Z-0478-2018	Class II	Terminated	Voluntary: Firm initiated	2018-02-07	2018-01-29
Z-0479-2018	Class II	Terminated	Voluntary: Firm initiated	2018-02-07	2018-01-29
Z-0480-2018	Class II	Terminated	Voluntary: Firm initiated	2018-02-07	2018-01-29
Z-0481-2018	Class II	Terminated	Voluntary: Firm initiated	2018-02-07	2018-01-29
Z-0482-2018	Class II	Terminated	Voluntary: Firm initiated	2018-02-07	2018-01-29
Z-0483-2018	Class II	Terminated	Voluntary: Firm initiated	2018-02-07	2018-01-29
Z-0484-2018	Class II	Terminated	Voluntary: Firm initiated	2018-02-07	2018-01-29

Product code HSB

K100238Class IIHfn 125 Degree 9-13 Mm, 180Mm, Hfn 130 Degree 9-13 Mm, Hfn Rh 125 Degree 9-13MmDePuy Orthopaedics, Inc. / cleared 2010-05-11

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