Encore Medical, LP: Medical Device Recall in 2020 - (Recall #: Z-3021-2020)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2020.

Data Source: FDA.

Product Description:

RSP Standard HUMERAL SOCKET INSERT, 44MM, HXe-Plus, Part No. 509-00-044

Product Classification:

Class II

Date Initiated: August 7, 2020

Date Posted: October 7, 2020

Recall Number: Z-3021-2020

Event ID: 86317

Reason for Recall:

Product may be mislabeled with the size etched onto products differing from the size information shown on patient sticker labels. Risks associated with this issue may include the Surgeon implanting the incorrect size; significant physical impairment, discomfort and/or disruption of treatment of underlying condition; and the patient experiencing dislocation resulting in revision surgery.

Status: Ongoing

Product Quantity: 15 units

Code Information:

Part 509-00-044, Lot 380P1009A , UDI: 00888912144568

Distribution Pattern:

Distributed in the U.S. to: VA, MN, IN, RI, PA, NY, WA, KS, OK, FL, GA and CA

Voluntary or Mandated:

Voluntary: Firm initiated