RSP Humeral Socket Insert Size 36mm Semi-Constrained +4 mm, REF: 509-01-436, orthopedic shoulder implant component.
Reported: November 15, 2023 Initiated: September 25, 2023 #Z-0282-2024
Product Description
RSP Humeral Socket Insert Size 36mm Semi-Constrained +4 mm, REF: 509-01-436, orthopedic shoulder implant component.
Reason for Recall
Two different humeral socket Insert devices were swapped during packaging, which could result in surgeons not having the correct device for surgery, which could cause a delay in surgery.
Details
- Recalling Firm
- Encore Medical, LP
- Units Affected
- 20
- Distribution
- US: MN, TX, IN, OH, SC, RI, ME, NJ, NY, KS, LA, FL, CA
- Location
- Austin, TX
Frequently Asked Questions
What product was recalled? ▼
RSP Humeral Socket Insert Size 36mm Semi-Constrained +4 mm, REF: 509-01-436, orthopedic shoulder implant component.. Recalled by Encore Medical, LP. Units affected: 20.
Why was this product recalled? ▼
Two different humeral socket Insert devices were swapped during packaging, which could result in surgeons not having the correct device for surgery, which could cause a delay in surgery.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on November 15, 2023. Severity: Moderate. Recall number: Z-0282-2024.
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