Encore Medical, Lp: Medical Device Recall in 2017 - (Recall #: Z-1413-2017)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2017.

Data Source: FDA.

Product Description:

RSP Impaction Fixture

Product Classification:

Class II

Date Initiated: February 9, 2017

Date Posted: March 15, 2017

Recall Number: Z-1413-2017

Event ID: 76456

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.

Status: Terminated

Product Quantity: 626 units

Code Information:

109931L01, 109931L02, 115670L15, 115670L16, 128092L08, 128092L09, 137917L16, 167829L06, 52258L01, 52258L01A, 67428L01, 76386L01, 76386L02, 81722L01, 81722L02

Distribution Pattern:

US, South Korea, Australia, Canada, United Kingdom/Ireland, Germany

Voluntary or Mandated:

Voluntary: Firm initiated