RSP Humeral Socket Insert Size 36mm Semi-Constrained +4 mm, REF: 509-01-436, orthopedic shoulder implant component.
FDA Recall Z-0282-2024 · Posted 2023-11-08
Recalling FirmEncore Medical, LP
Recall StatusOpen, Classified
Product CodePHX
Date Initiated2023-09-25
Product Quantity20
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.
Firm Action
On 09/25/23, recall notices were emailed to Agents who were asked to do the following:
1) Pass the notice to all those within your organization or to any organization where the potentially affected product has been transferred.
2) Return all affected devices using the RMA number.
3) Complete and return the response form.
Questions can be directed to [email protected]
Root Cause
Labeling Change Control
Distribution Pattern
US: MN, TX, IN, OH, SC, RI, ME, NJ, NY, KS, LA, FL, CA
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.