RSP Humeral Socket Insert (Unknown) – Device Swap Risk (2023)
Device packaging swap may cause potential surgical procedure complications.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
RSP Humeral Small Socket Insert Size 32 mm Semi-Constrained +4, e-plus, REF: 509-03-432, orthopedic shoulder implant component.
Lot Codes / Batch Numbers
UDI-DI: 00190446257585, Lot: 954W1194
Products Sold
UDI-DI: 00190446257585, Lot: 954W1194
A medical device manufacturer is recalling RSP Humeral Small Socket Insert Size 32 mm Semi-Constrained +4, e-plus, REF: 509-03-432, orthopedic due to Two different humeral socket Insert devices were swapped during packaging, which could result in surgeons not having the correct device for surgery, w. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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 livia.kuruvila@enovis.com
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
CA, FL, IN, KS, LA, ME, MN, NJ, NY, OH, RI, SC, TX
Page updated: Jan 10, 2026