Medical device recalls

Patient results determined using this calibrator lot might deviate up to 20%. Controls might not indicate false values.

The Operating Room Table may drift while in use, which could potentially result in unintended movement of the table.

The Operating Room Table may drift while in use, which could potentially result in unintended movement of the table.

The Operating Room Table may drift while in use, which could potentially result in unintended movement of the table.

The Operating Room Table may drift while in use, which could potentially result in unintended movement of the table.

The recalling firm has become aware that the rail section clamps used to attach the leg support of the device may fail during use, which could result in critical harm to the patient.

When the archiving configuration is changed, data received/created after the upgrade may be flagged as "Not to be archived". This is caused by the automatic function for cleaning up temporary data being disabled by the software upgrade. Due to the disabled cleanup function, disc capacity for free space decreases faster than usual. Unless the archiving configuration and the cleanup automatic function are reverted back to the original state (prior to the software upgrade), data that was incorrectly flagged "Not to be archived" must be manually prevented from being deleted by either clinical administrator or service engineer.

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 804-07-540) is much larger on the trails than on the implants

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 804-07-540) is much larger on the trails than on the implants

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 804-07-540) is much larger on the trails than on the implants

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 804-07-540) is much larger on the trails than on the implants

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 804-07-540) is much larger on the trails than on the implants

Lack of sterility assurance as bioburden levels were found to be higher than internal acceptable rates.

Lack of sterility assurance as bioburden levels were found to be higher than internal acceptable rates.

Lack of sterility assurance as bioburden levels were found to be higher than internal acceptable rates.

Lack of sterility assurance as bioburden levels were found to be higher than internal acceptable rates.

Lack of sterility assurance as bioburden levels were found to be higher than internal acceptable rates.

Lack of sterility assurance as bioburden levels were found to be higher than internal acceptable rates.

Lack of sterility assurance as bioburden levels were found to be higher than internal acceptable rates.

Lack of sterility assurance as bioburden levels were found to be higher than internal acceptable rates.

Lack of sterility assurance as bioburden levels were found to be higher than internal acceptable rates.

Lack of sterility assurance as bioburden levels were found to be higher than internal acceptable rates.

Lack of sterility assurance as bioburden levels were found to be higher than internal acceptable rates.

Lack of sterility assurance as bioburden levels were found to be higher than internal acceptable rates.

Lack of sterility assurance as bioburden levels were found to be higher than internal acceptable rates.

The firm made multiple changes to the product requiring the submission of a new 510(k) premarket notification.

Broken or missing screws and retaining clips. This may be due to screw tolerance and material strength of the trial.

Zimmer Biomet is conducting a medical device recall for the Persona Partial Knee Spacer Blocks in sizes 8mm, 9mm, 10mm, 12mm, and 14mm. Complaints received indicated that flexion has the potential to feel tight during range-of-motion trialing and that the final trial has the potential to appear looser in extension.

One lot of humeral stem implants do not include the humeral bushing components.

Certain partial knee implant spacer blocks do not fit in the alignment tower instrument or handle.