Encore Medical Recalls Exprt Precision System Hip Implant Components
Encore Medical is recalling 22 units of Exprt Precision System hip implant components due to loose or improperly seated bolts that may cause pain or require revision surgery.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II and involves a structural defect in a medical implant that may result in significant injury, including the need for revision surgery.
Plain-English summary
Encore Medical, Lp is recalling 22 units of the Exprt Precision System: Revision Hip, Proximal Body with Bolt, Lateral Offset, Sterile R, manufactured by djo surgical. The affected reference numbers are 495-00-065, 495-00-075, 495-00-085, 495-01-065, 495-01-075, and 495-01-085. The recall covers all lots of these specific items.
The recall was initiated due to complaints regarding loose proximal body bolts or bolts that were found via x-ray to be sitting above the proximal body and not properly seated. The FDA classifies this as a Class II recall. Patient risks associated with this defect include pain, dissociation, and the possibility of requiring revision surgery.
The affected products were distributed to facilities in the following states: TN, MN, TX, CO, IL, IN, OH, SC, MS, MI, RI, PA, ME, NY, WA, MO, AR, OK, LA, AL, FL, GA, UT, AZ, CA, and NV. Healthcare providers and patients should contact their surgeon or the recalling firm for instructions on how to proceed.
The recalled product
- Product
- Exprt Precision System: Revision Hip, Proximal Body with Bolt, Lateral Offset, Sterile R, djo surgical, REF: 495-00-065, 495-00-075, 495-00-085, 495-01-065, 495-01-075, 495-01-085
- Manufacturer
- Encore Medical, Lp
- Affected units
- 22
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)
- All lots.
Distribution
Related recalls
Same manufacturer · Encore Medical, Lp
See all →- ModerateEMPOWR 3D KNEE insertion instruments recalled for incorrect product size packaging
FDA (Devices) · 2026-07-15
- ModerateEMPOWR 3D Knee surgical device recalled due to packaging discrepancy
FDA (Devices) · 2026-07-15
- SevereReverse Shoulder Prosthesis Implants Recalled Over Incorrect Labeling
FDA (Devices) · 2026-03-04
- HighShoulder prosthesis humeral socket inserts recalled over incorrect implant labeling
FDA (Devices) · 2026-03-04
- SevereKnee and Humeral Socket Implants Recalled for Incorrect Labeling
FDA (Devices) · 2026-03-04
Same hazard · structural defect
See all →- SevereSubaru Recalls 2026 Forester and Crosstrek for Ball Joint Defect
NHTSA · 2026-10-19
- SevereVolvo Recalls 2025-2026 VNL Trucks for Loose Structural Bolts
NHTSA · 2026-10-15
- Severe
- SevereVolvo Recalls EX30 and EX30CC Vehicles for Head Restraint Defect
NHTSA · 2026-10-09
- Severe
Similar recalls
- ModerateEncore Medical Recalls Exprt Precision System Knee Implants for Missing Labeling
FDA (Devices) · 2015-11-04
- HighEncore Medical Recalls EMPOWR Locking Femoral Impactor Due to Tip Breakage
FDA (Devices) · 2019-12-18
- HighEncore Medical Recalls LIMA Modular Revision Hip Stems Due to Sterilization Error
FDA (Devices) · 2017-02-22
- ModerateReverse Shoulder Joint Implant System Recalled for Mislabeling
FDA (Devices) · 2024-01-10
- HighEncore Medical Recalls AltiVate Reverse Humeral Broach Due to Undersized Feature
FDA (Devices) · 2016-01-20
- HighEncore Medical Recalls Humeral Socket Inserts Due to Size Mismatch
FDA (Devices) · 2020-10-07