Z-1692-2020Class II

djosurgical Linear Neck Trials with Spring Sides, Standard, nonsterile, REF S-200635; and djosurgical Linear...

Name: Z-1692-2020 djosurgical Linear Neck Trials with Spring Sides, Standard, nonsterile, REF S-200635; and djosurgical Linear...
Creator: Encore Medical, LP
Published: 2018-07-10
License: https://open.fda.gov/license/

Encore Medical, LP / initiated 2018-07-10 / Open, Classified / root cause: manufacturing process

FDA source

Encore Medical, LP began a recall of djosurgical Linear Neck Trials with Spring Sides, Standard, nonsterile, REF S-200635; and djosurgical Linear Neck Trials with Spring Sides, Lateral... on 2018-07-10. FDA classified it as Class II and gives the reason as "The retaining ring on the neck trials has a potential to fail interoperatively". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1692-2020
Classification: Class II
Status: Open, Classified
Initiated: 2018-07-10
Posted: 2020-04-10
Recalling firm: Encore Medical, LP
Product: djosurgical Linear Neck Trials with Spring Sides, Standard, nonsterile, REF S-200635; and djosurgical Linear Neck Trials with Spring Sides, Lateral, nonsterile, REF S-200636. The firm name on the label is djosurgical, Austin, TX.
Product code: LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
Reason for recall: The retaining ring on the neck trials has a potential to fail interoperatively.
Root cause tag: manufacturing process
FDA root cause: Process design
Action: The recalling firm issued a letter dated 7/10/2018 to their field representatives (agencies) via email explaining the reason for recall.
Quantity in commerce: 28 (14 REF S200635 and 14 S200636)
Distribution: Distribution was made to CA, CO, MD, MN, OH, TX, and WA. There was no foreign/military/government distribution.
Product codes and lots: All Revision C trials. REF S-2000635: 313R1000, 313R1900, 313R1901; REF S-200636: 314R1000, 314R1900, 314R1901.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1692-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1692-2020	Class II	Ongoing	Voluntary: Firm initiated	2020-04-22	2020-04-10

Product code LPH

K120241Class IILinear Hip Stem, Size 5Encore Medical L.P. / cleared 2012-02-24

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)