FDA recall Z-2430-2018

Product

Apollo XT Suture Anchor, 5.5 x 15 Product Usage: Apollo XT Suture Anchors are intended for: Shoulder - Rotator Cuff Repair - Bankart Repair - SLAP Lesion Repair - Biceps Tenodesis - Acromio-Clavicular Separation Repair - Deltoid Repair - Capisular Shift or Capsulolabral Reconstruction Foot/Ankle - Lateral Stabilization - Medial Stabilization - Achilles Tendon Repair Knee - Medial Collateral Ligament Repair - Lateral Collateral Ligament Repair - Posterior Oblique Ligament Repair - Illiotibial Band Tenodesis Elbow - Biceps Tendon Reattachment - Ulnar or Radial Collateral Ligament Reconstruction Hip - Capsular Repair - Acetabular Labral Repair

Reason for recall

The label on Apollo XT 5.5mm Suture Anchor (part # XTS-5515; lots 2358, 2362, and 2363) indicated that the anchor screw material was titanium, however that part number is made of PEEK.

Distribution

US Nationwide Distribution in the states of California and Oklahoma.

Key facts

Status

Terminated

Initiation date

2018-01-22

Report date

2018-07-25

Termination date

2021-04-09

Voluntary/Mandated

Voluntary: Firm initiated

Location

Marietta, GA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2430-2018