Recall Z-3022-2020— Encore Medical, LP

Name: FDA recall Z-3022-2020
Creator: U.S. Food and Drug Administration
Published: 2020-08-07

Class II · Ongoing

Class II FDA medical device recall by Encore Medical, LP, initiated 2020-08-07. It names one FDA 510(k) clearance: K141006. Product: RSP Standard HUMERAL SOCKET INSERT, 40 MM plus 4MM, HXe-Plus, Part No. 509-00-440. Reason: 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..

Recalling firm: Encore Medical, LP
Classification: Class II
Status: Ongoing
Initiated: 2020-08-07
Firm location: Austin, TX, United States

510(k) clearances named in this recall

1 on FDA's record

K141006 — RSP HUMERAL SOCKET INSERTDjo Global·cleared 2014-06-05

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

RSP Standard HUMERAL SOCKET INSERT, 40 MM plus 4MM, HXe-Plus, Part No. 509-00-440

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.