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Terminated

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 Recall Z-0709-2019 · Posted None

Recalling FirmZimmer Biomet, Inc.
Recall StatusTerminated
Product CodeLXT
Date Initiated2018-11-20
Date Terminated2020-04-14
Product Quantity50 pieces

Reason for Recall

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

Firm Action

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.

Root Cause

Packaging process control

Distribution Pattern

Country of Japan

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K112345DISTAL VOLAR RADIUS PLATING SYSTEMSMedos International SARL · 2011-10-31

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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