CLASS II ONGOING Device recall · Reported 27 Sep 2023 · FDA Enforcement Report
DJO Surgical: Reverse Shoulder System recalled by Encore Medical
Encore Medical is recalling DJO Surgical: Reverse Shoulder System (RSP) Semi Humeral Socket Insert, distributed in 26 states. The recall was initiated on 4 Aug 2023 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2606-2023
- FDA event ID
- 92969
- Recalling firm
- Encore Medical, Austin, TX
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 4 Aug 2023
- FDA classified
- 19 Sep 2023
- Reported
- 27 Sep 2023
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Lead & Heavy Metals
- Device type
- Surgical Instruments
Timeline
| 4 Aug 2023 | Recall initiated by company | |
| 19 Sep 2023 | Classified by FDA | +46 days |
| 27 Sep 2023 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Orthopedic device components were not subjected to final sterilization before shipment, which if implanted may lead to varying degrees of infection, which may require treatment, prolonged monitoring, and may lead to revision surgery
Lead and other heavy metals accumulate in the body. Children are most at risk; even low levels can affect development.
Product as listed by the FDA
DJO Surgical: Reverse Shoulder System (RSP) Semi Humeral Socket Insert, 32mm, REF: 508-01-032; Baseplate, Glenoid HA-Coat, RSP, 6.5mm X 30mm, REF: 508-32-104; Reverse Shoulder System (RSP) Glenoid, Neutral Head W/ Retaining Screw, 36mm, REF: 508-36-101
Where it was distributed
US: AL, AZ, CA, CO, FL, IL, IN, KS, KY, LA, MA, MI, MN, MO, NC, NJ, NY, OH, PA, PR, RI, SC, TX, UT, VA, WA. OUS: Sweden, Australia, France, UK, Colombia, Germany
AlabamaArizonaCaliforniaColoradoFloridaIllinoisIndianaKansasKentuckyLouisianaMassachusettsMichiganMinnesotaMissouriNorth CarolinaNew JerseyNew YorkOhioPennsylvaniaPuerto Rico
Questions about this recall
Is DJO Surgical: Reverse Shoulder System (RSP) Semi Humeral Socket Insert recalled?
Yes. Encore Medical recalled DJO Surgical: Reverse Shoulder System (RSP) Semi Humeral Socket Insert on 4 Aug 2023. The recall is Class II and its status is Ongoing. Recall number Z-2606-2023.
Why was it recalled?
Orthopedic device components were not subjected to final sterilization before shipment, which if implanted may lead to varying degrees of infection, which may require treatment, prolonged monitoring, and may lead to revision surgery
Which lots are affected?
REF/UDI-DI/Lot/Expiration: 508-01-032/00888912024693/859C1190/April 29, 2027; 508-32-104/00888912024754/866C3153/May 25, 2029 and 866C3147/April 3, 2029; 508-36-101/869C3539/April 30, 2028
Where was it sold?
US: AL, AZ, CA, CO, FL, IL, IN, KS, KY, LA, MA, MI, MN, MO, NC, NJ, NY, OH, PA, PR, RI, SC, TX, UT, VA, WA. OUS: Sweden, Australia, France, UK, Colombia, Germany
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Encore Medical
All 99| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Empowr 3d Knee Ins, Ve recalled by Encore Medical | Encore Medical | Packaging Defects | 14 states |
| Device | CLASS II | Empowr 3d Knee Ins, Ve recalled by Encore Medical | Encore Medical | Packaging Defects | 14 states |
| Device | CLASS II | Empowr 3d Knee Ins, Ve recalled by Encore Medical | Encore Medical | Labeling Errors | Nationwide |
| Device | CLASS II | Reverse Shoulder Prosthesis recalled by Encore Medical | Encore Medical | Labeling Errors | Nationwide |
| Device | CLASS II | Reverse Shoulder Prosthesis recalled by Encore Medical | Encore Medical | Labeling Errors | Nationwide |
Other Surgical Instruments recalls
All 3,809| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Medline Convenience Kits: IV Start KIT recalled by Medline Industries | Medline Industries | Sterility | Nationwide |
| Device | CLASS II | Medline Convenience Kits containing BD ChloraPrep Clear recalled | Medline Industries | Lead & Heavy Metals | Nationwide |
| Device | CLASS II | Medline convenience kits labeled as: Open Heart Pack, Medline Kit recalled | Medline Industries | Other | Nationwide |
| Device | CLASS II | Medline convenience kits labeled as: GYN Robotic CDS, Medline Kit recalled | Medline Industries | Other | Nationwide |
| Device | CLASS II | Linvatec Genesys CrossFT Suture Anchor with Disposable Driver recalled | ConMed | Sterility | Nationwide |