All-Poly e+ Patella (Unknown) – Mislabeling (2023)
Mislabeling may cause minor confusion for medical professionals.
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
REF 130-03-738, All-Poly e + Patella, Domed Tri-Peg, 9x38mm, STERILE H2O2
Lot Codes / Batch Numbers
UDI: (01)00888912108560/Lot Number(s): 157N1556
Products Sold
UDI: (01)00888912108560/Lot Number(s): 157N1556
A medical device manufacturer is recalling REF 130-03-738, All-Poly e + Patella, Domed Tri-Peg, 9x38mm, STERILE H2O2 due to Mislabeling. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Mislabeling
Recommended Action
Per FDA guidance
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.
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 noticePage updated: Jan 10, 2026