FDA-Device2020-10-07Class II
RSP Standard HUMERAL SOCKET INSERT, 40 MM plus 4MM, HXe-Plus, Part No. 509-00-440
Encore Medical, LP
Hazard
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.
Sold states
Distributed in the U.S. to: VA, MN, IN, RI, PA, NY, WA, KS, OK, FL, GA and CA
Affected count
37 units
Manufactured in
9800 Metric Blvd, N/A, Austin, TX, United States
Products
RSP Standard HUMERAL SOCKET INSERT, 40 MM plus 4MM, HXe-Plus, Part No. 509-00-440
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3022-2020Don't want to check this manually?
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