Z-2242-2016Class II

MODIFIED LINEAR STANDARD/LATERAL NECK TRIALS WITH SPRING SIDES REF S-200635 and S-200636

Name: Z-2242-2016 MODIFIED LINEAR STANDARD/LATERAL NECK TRIALS WITH SPRING SIDES REF S-200635 and S-200636
Creator: Encore Medical, Lp
Published: 2016-06-21
License: https://open.fda.gov/license/

Encore Medical, LP / initiated 2016-06-21 / Terminated / root cause: manufacturing process

FDA source

Encore Medical, Lp began a recall of MODIFIED LINEAR STANDARD/LATERAL NECK TRIALS WITH SPRING SIDES REF S-200635 and S-200636 on 2016-06-21. FDA classified it as Class II and gives the reason as "Reported failure of the instrument. The retaining ring component of a neck trial became disassembled from the body of the neck". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2242-2016
Classification: Class II
Status: Terminated
Initiated: 2016-06-21
Posted: 2016-07-19
Terminated: 2017-01-10
Recalling firm: Encore Medical, LP
Product: MODIFIED LINEAR STANDARD/LATERAL NECK TRIALS WITH SPRING SIDES REF S-200635 and S-200636
Product code: LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
Reason for recall: Reported failure of the instrument. The retaining ring component of a neck trial became disassembled from the body of the neck.
Root cause tag: manufacturing process
FDA root cause: Process design
Action: The recalling firm notified affected consignees via letter on 6/21/16. The consignees were instructed to return the affected devices.
Quantity in commerce: 14 (7 sets)
Distribution: CO, ID, TX
Product codes and lots: Lot: 313R1000, 313R1900, 313R1901, 314R1000, 314R1900, 314R1901

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2242-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2242-2016	Class II	Terminated	Voluntary: Firm initiated	2016-07-27	2016-07-19

Product code LPH

K974294Class IIEncore Linear Porous Coated HipEncore Orthopedics, Inc. / cleared 1998-01-12

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)