Overview of recall records associated with Encore Medical, Lp, including dates, categories and classifications where available.
Classification mix: Class II: 64.
There is a potential for the retaining pin of the tibial punch handle to become loose and fall out while impacting. If undetected, there is a potential of leaving debris in the joint space.
Product may be mislabeled with the size etched onto products differing from the size information shown on patient sticker labels. Risks associated with this issue may include the Surgeon…
Product may be mislabeled with the size etched onto products differing from the size information shown on patient sticker labels. Risks associated with this issue may include the Surgeon…
The firm received complaints that the EMPOWR Acetabular Impactor Balls were fracturing/cracking during impaction which could cause debris to migrate or be left in the joint space.
The retaining ring on the neck trials has a potential to fail interoperatively.
The firm has received reports/complaints concerning the breakage of the tips of the locking femoral Impactor. Additionally, if the impactor is not seated correctly on the implant prior to…
Manufacturing error, the drill bit shaft is unable to properly capture the drill bit pin. Failure of the drill bit shaft to capture the drill bit pin could result in the drill bit coming…
Complaints regarding loose proximal body bolts or bolts that were found through x-ray as sitting above the proximal body and not properly seated. Patient risks may include: pain,…
After receipt of a product complaint for the labeling, it was determined that this device does not have FDA clearance.
A black, aluminum oxide coating may appear on the tray after cleaning. The black, aluminum oxide coating is not biocompatible.
It was discovered during a surgery that the design of the radius at the base of the pegs of the Anatomic Glenoid Trial (Part Numbers: 804-07-380, 804-07-420, 804-07-460, 804-07-500, and…
It was discovered during a surgery that the design of the radius at the base of the pegs of the Anatomic Glenoid Trial (Part Numbers: 804-07-380, 804-07-420, 804-07-460, 804-07-500, and…
It was discovered during a surgery that the design of the radius at the base of the pegs of the Anatomic Glenoid Trial (Part Numbers: 804-07-380, 804-07-420, 804-07-460, 804-07-500, and…
Broken or missing screws and retaining clips. This may be due to screw tolerance and material strength of the trial.
It was discovered during a surgery that the design of the radius at the base of the pegs of the Anatomic Glenoid Trial (Part Numbers: 804-07-380, 804-07-420, 804-07-460, 804-07-500, and…
It was discovered during a surgery that the design of the radius at the base of the pegs of the Anatomic Glenoid Trial (Part Numbers: 804-07-380, 804-07-420, 804-07-460, 804-07-500, and…
This page summarizes recall records in which the official source identifies Encore Medical, Lp as the recalling firm or manufacturer. The number of records should not be treated as a safety rating or a measure of company size, because recall counts depend on product mix, reporting periods and how government records are organized.
Compare the dates, categories and classifications together rather than relying on the total alone. Open an individual record for the recalled product, reason, distribution details and current instructions available from the source.
