Z-1413-2017Class II

RSP Impaction Fixture

Name: Z-1413-2017 RSP Impaction Fixture
Creator: Encore Medical, Lp
Published: 2017-02-09
License: https://open.fda.gov/license/

Encore Medical, LP / initiated 2017-02-09 / Terminated / root cause: design

FDA source

Encore Medical, Lp began a recall of RSP Impaction Fixture on 2017-02-09. FDA classified it as Class II and gives the reason as "During the Turon assembly, the impaction forces caused the polymer, black acetal copolymer from the Impaction Fixture to wear off on the lateral surface of the Humeral Stem titanium plasma spray coating". 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-1413-2017
Classification: Class II
Status: Terminated
Initiated: 2017-02-09
Posted: 2017-03-08
Terminated: 2017-10-20
Recalling firm: Encore Medical, LP
Product: RSP Impaction Fixture
Product code: HWA Impactor
Reason for recall: During the Turon assembly, the impaction forces caused the polymer, black acetal copolymer from the Impaction Fixture to wear off on the lateral surface of the Humeral Stem titanium plasma spray coating.
Root cause tag: design
FDA root cause: Device Design
Action: There are two field safety notices, one for Consignees who have surgeons that use the impaction fixtures (Verson 1) and one for Consignees who had previously indicated their surgeons do NOT use the impaction fixtures (Verson 2). The two recall notification letters were sent out on 2/9/17.
Quantity in commerce: 626 units
Distribution: US, South Korea, Australia, Canada, United Kingdom/Ireland, Germany
Product codes and lots: 109931L01, 109931L02, 115670L15, 115670L16, 128092L08, 128092L09, 137917L16, 167829L06, 52258L01, 52258L01A, 67428L01, 76386L01, 76386L02, 81722L01, 81722L02

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1413-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1412-2017	Class II	Terminated	Voluntary: Firm initiated	2017-03-15	2017-03-08
Z-1413-2017	Class II	Terminated	Voluntary: Firm initiated	2017-03-15	2017-03-08

Product code HWA

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)