Exact FDA event identifier

Event 98340

3 recalled-product records grouped only because every row carries this exact official event ID.

Event summary

Timeline bucket: January 15, 2026
Product types: Device
Classifications: Class II
Statuses: Ongoing
Recalling firm wording: Encore Medical, LP

Dossier provenance

Source snapshots represented here

openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

3 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 3

Brand Name: Reverse Shoulder Prosthesis (RSP) Product Name: RSP HUMERAL SOCKET INSERT, 32MM +4MM, STANDARD HXe-plus Model/Catalog Number: 509-00-432

Z-1458-2026

Recall number: Z-1458-2026
Initiated: January 15, 2026
Classification: Class II
Status: Ongoing
Recalling firm: Encore Medical, LP
Quantity: 20 implants

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0

incorrect labeling

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Knee and Humeral socket implants contain incorrect labeling.

Code information

Lot Code: Lot: 385P1263 GTIN: 00888912144575

Distribution pattern

US Nationwide distribution in the states of VA, TN, IL, IN, MI, CO, WY, MT, RI, MA, NJ, PA, MO, OK, LA, FL, CA.

device · product 2 of 3

Brand Name: EMPOWR 3D KNEE Product Name: EMPOWR 3D KNEE INS, 7L 16MM, VE Model/Catalog Number: 341-16-707

Z-1459-2026

Recall number: Z-1459-2026
Initiated: January 15, 2026
Classification: Class II
Status: Ongoing
Recalling firm: Encore Medical, LP
Quantity: 14 implants

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0

incorrect labeling

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Knee and Humeral socket implants contain incorrect labeling.

Code information

Lot Code: Lot: 151T1055A GTIN: 00888912167147

Distribution pattern

US Nationwide distribution in the states of VA, TN, IL, IN, MI, CO, WY, MT, RI, MA, NJ, PA, MO, OK, LA, FL, CA.

device · product 3 of 3

Brand Name: Reverse Shoulder Prosthesis (RSP) Product Name: RSP STANDARD HUMERAL SOCKET INSERT, 36MM, HXe-plus Model/Catalog Number: 509-00-036

Z-1460-2026

Recall number: Z-1460-2026
Initiated: January 15, 2026
Classification: Class II
Status: Ongoing
Recalling firm: Encore Medical, LP
Quantity: 20 implants

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0

incorrect labeling

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Knee and Humeral socket implants contain incorrect labeling.

Code information

Lot Code: Lot: 378P1382 GTIN: 00888912144544

Distribution pattern

US Nationwide distribution in the states of VA, TN, IL, IN, MI, CO, WY, MT, RI, MA, NJ, PA, MO, OK, LA, FL, CA.