—#169577

Product

Biomet DVR Crosslock Screws- 2.7mm x18mm, Sterile ITEM 131827118 Product Usage: Usage: The system is intended for stabilization and fixation of small bone fragments in fresh fractures, revision procedures, joint fusion and reconstructions (osteotomies) of small bones of the hand, foot, radius, ulna, ankle, humerus, scapula and pelvis, particularly in osteopenic bone

FDA product code: LXT — Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite
Device class: Class 2
Medical specialty: Orthopedic
510(k) numbers: K112345
Affected lot / code info: LOT 029970 UDI (01)00880304535572(17)280501(10)029970

Why it was recalled

One lot of product labeled 2.7mm x18mm Lock Screw Square Drive (Lot 029970) contains 20mm locking screws and one lot of product labeled 2.7mm x 20mm Lock Screw Square Drive (Lot 029980) contains 18mm locking screws

Root cause (FDA determination)

Packaging process control

Action the firm took

Zimmer Biomet issued Urgent Medical Device Recall letter on 11/20/18 advising of the problem, heath risk and action to be taken- Quarantine and return product. Complete Attachment 1 Certificate of Acknowledgement. Contact customer service at 574-371-3071 between 8:00 am and 5:00pm EST, Monday through Friday.

Recalling firm

Firm: Zimmer Biomet, Inc.
Address: 56 E Bell Dr, Warsaw, Indiana 46582-6989

Distribution

Distribution pattern: Country of Japan

Timeline

Recall initiated: 2018-11-20
Terminated: 2020-04-14
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #169577. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.