Z-3102-2017Class II

MODIFIED/SPECIAL INSTRUMENT, TURON GLENOID REAMER, REAM AND RUN, Catalog Numbers: REF S-200956 - 5mm PIN...

Name: Z-3102-2017 MODIFIED/SPECIAL INSTRUMENT, TURON GLENOID REAMER, REAM AND RUN, Catalog Numbers: REF S-200956 - 5mm PIN...
Creator: Encore Medical, Lp
Published: 2017-08-04
License: https://open.fda.gov/license/

Encore Medical, LP / initiated 2017-08-04 / Terminated / root cause: manufacturing process

FDA source

Encore Medical, Lp began a recall of MODIFIED/SPECIAL INSTRUMENT, TURON GLENOID REAMER, REAM AND RUN, Catalog Numbers: REF S-200956 - 5mm PIN, SIZE 46 REF S-200957 - 5mm PIN, SIZE 50 REF S-200958... on 2017-08-04. FDA classified it as Class II and gives the reason as "It was reported that the models used to manufacture S-200956/958 had the wrong dimension used to create the spherical radius cutting surface. Device design allows a larger spherical radius cutting surface than intended". 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-3102-2017
Classification: Class II
Status: Terminated
Initiated: 2017-08-04
Posted: 2017-08-31
Terminated: 2023-06-28
Recalling firm: Encore Medical, LP
Product: MODIFIED/SPECIAL INSTRUMENT, TURON GLENOID REAMER, REAM AND RUN, Catalog Numbers: REF S-200956 - 5mm PIN, SIZE 46 REF S-200957 - 5mm PIN, SIZE 50 REF S-200958 - 5mm PIN, SIZE 58
Product code: HTO Reamer
Reason for recall: It was reported that the models used to manufacture S-200956/958 had the wrong dimension used to create the spherical radius cutting surface. Device design allows a larger spherical radius cutting surface than intended.
Root cause tag: manufacturing process
FDA root cause: Employee error
Action: The firm initiated their recall by telephone and email to their sales representatives and surgeons on 08/04/2017. The letter explained the problem and advised the surgeons that the sales representative would be collecting the devices for return.
Quantity in commerce: 5 units
Distribution: OH, VA
Product codes and lots: Catalog number, Lot Number S-200956, 535U1000 S-200957, 536U1000 S-200958, 537U1000

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-3102-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-3102-2017	Class II	Terminated	Voluntary: Firm initiated	2017-09-06	2017-08-30

Product code HTO

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)