Knee Prosthesis Recall: Packaging Mixup May Cause Wrong Size Implantation
Encore Medical recalls DJO Surgical EMPOWR 3D knee prosthetic components because packaging labels may not match the product inside, risking implantation of incorrect prosthesis sizes.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II medical device recall involving risk of incorrect prosthesis size implantation due to packaging mixup. No illnesses or injuries have been reported. Per the rubric, risk-of-harm products where injury has not yet been reported score as High (3).
Plain-English summary
Encore Medical, LP is recalling DJO Surgical EMPOWR 3D Knee Tibial Insert components due to a packaging mixup. Packaging labeled as containing 12mm prostheses may actually contain 16mm prostheses, and 16mm packaging may contain 12mm prostheses.
Ten units of the affected product were distributed to healthcare facilities in Virginia, Minnesota, Texas, Illinois, Mississippi, California, Kansas, Louisiana, and Georgia. The affected lot number is 115T1035 (REF: 341-12-711).
Patients and healthcare facilities who have received these components should contact Encore Medical or their distributor to verify the correct prosthesis size was received and to arrange replacement if necessary.
The recalled product
- Product
- DJO Surgical EMPOWR 3D Knee Tibial Insert - e-plus, REF: 341-12-711, Left Sz. 11 12mm, CE0086, Sterile H2O2, UDI: (01)00888912166980
- Manufacturer
- Encore Medical, LP
- Affected units
- 10
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lot # 115T1035
Distribution
Part of a larger recall action
This product is one of 2 recalled by Encore Medical, LP under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 2 products in this recall →Related recalls
Same manufacturer · Encore Medical, LP
See all →- ModerateEMPOWR 3D KNEE insertion instruments recalled for incorrect product size packaging
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