Recall Z-0626-2024
Encore Medical, LP · initiated October 5, 2023
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
REF 130-03-738, All-Poly e + Patella, Domed Tri-Peg, 9x38mm, STERILE H2O2
Codes / lots: UDI: (01)00888912108560/Lot Number(s): 157N1556
Reason for recall
Mislabeling
FDA-determined cause: Packaging process control
Action taken
On October 5, 2022, DJO Global (Enovis company) issued a "Urgent Medical Device Recall" Notification via E-Mail. DJO asked consignees to take the following actions: 1. This notice needs to be passed on to all those within your organization or to any organization where the potentially affected product has been transferred. 2. Review your stock for the affected products and lot numbers for the items to be returned. 3. Complete acknowledgement and response form and contact Customer Service at 1-800-456-8696 to place a replacement order and receive an RMA number. You will be provided with a shipping label to return the affected product. 4. Return all affected devices (quantities listed above) using the RMA number. Report any adverse events related to this issue to Customer Service. Additionally, adverse reactions or quality problems experienced with the use of this product may be reported to the FDA s MedWatch Adverse Event Reporting program either online, by regular mail or by fax.
Details
- Recall number
- Z-0626-2024
- Initiated
- October 5, 2023
- Posted by FDA
- January 2, 2024
- Product code
- PHX – Shoulder Prosthesis, Reverse Configuration
- Quantity
- 2 units
- Distribution
- US Nationwide distribution in the states of VA, TN, MN, IN, RI, ME, TX, LA, AL, FL, CA.
- Recalling firm
- Encore Medical, LP, Austin, TX
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0625-2024 Class II | Reverse Shoulder System e+, REF 509-01-032, RSP Humeral Socket Insert, Sz. 32mm…Mislabeling | 10/05/2023Completed |