RSP Standard HUMERAL SOCKET INSERT, 44MM, HXe-Plus, Part… recallZ-3021-2020 · Encore Medical, LP · initiated Aug 7, 2020
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Encore Medical, LP or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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.
FDA root cause category: Other
What the company is doing
Letters were sent to the firm's Field/Sales Agents by email beginning on August 7, 2020. The letters included instructions to take the following actions by August 21, 2020: 1. Pass the notice on to all those within your organization or to any organization where the potentially affected product has been transferred, 2.Contact Customer Service at 1-800-456- 8696 to place a replacement order and receive a Return Materials Authorization (RMA) number, and to be provided with a shipping label to return the affected product. 3. Return all affected devices using the RMA number, and 4. Report any adverse events related to this issue to Customer Service. Customers with questions should contact Christine Chesnutt at 512-834-6207 or [email protected].
Recall details
- Recall number
- Z-3021-2020
- Status
- Open, Classified
- Initiated by the company
- Aug 7, 2020
- Recalling firm
- Encore Medical, LP
- Quantity
- 15 units
- Product code
- PHX
- FDA submissions
- K141006
- Distribution
- Distributed in the U.S. to: VA, MN, IN, RI, PA, NY, WA, KS, OK, FL, GA and CA
Product description
RSP Standard HUMERAL SOCKET INSERT, 44MM, HXe-Plus, Part No. 509-00-044
Code information (models, lots, serial numbers)
Part 509-00-044, Lot 380P1009A , UDI: 00888912144568
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- DJO SURGICAL 509-00-044Encore Medical, L.P. · PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED1 recall28 reports
Other devices under the same FDA submission
3 devices cleared under K141006 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.
- DJO SURGICAL 509-00-444Encore Medical, L.P. · PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED18 reports
- DJO SURGICAL 509-01-444Encore Medical, L.P. · PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED15 reports
- DJO SURGICAL 509-01-044Encore Medical, L.P. · PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED13 reports
Other products in the same recall event
The FDA groups related products into one recall event (event 86317).
- Z-3022-2020 · Open, ClassifiedRSP Standard HUMERAL SOCKET INSERT, 40 MM plus 4MM, HXe-Plus, Part No. 509-00-440
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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