RSP Standard HUMERAL SOCKET INSERT, 44MM, HXe-Plus, Part No. 509-00-044 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
RSP Standard HUMERAL SOCKET INSERT, 44MM, HXe-Plus, Part No. 509-00-044
Lot Codes / Batch Numbers
Part 509-00-044, Lot 380P1009A, UDI: 00888912144568
Products Sold
Part 509-00-044, Lot 380P1009A , UDI: 00888912144568
A medical device manufacturer is recalling RSP Standard HUMERAL SOCKET INSERT, 44MM, HXe-Plus, Part No. 509-00-044 due to Product may be mislabeled with the size etched onto products differing from the size information shown on patient sticker labels. Risks associated wit. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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 christine.chesnutt@djoglobal.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, GA, IN, KS, MN, NY, OK, PA, RI, VA, WA
Page updated: Jan 10, 2026