—#152772

Product

16 mm [or 18 mm] Distraction Pin, Qty: 1 per pack; STERILE; Manufactured for: Medline Industries, Inc., Mundelein, IL 60060 USA Distraction Pin is designed for Anterior Cervical Fusion Procedures. Use with vertebral body distraction instruments. It is intended as a temporary fixation screw utilized during cervical spine procedures.

FDA product code: LXH — Orthopedic Manual Surgical Instrument
Device class: Class 1
Medical specialty: Orthopedic
Affected lot / code info: 16 mm Pin: Item# MDS9091212; Lots #136469, 136754 | 18 mm Pin: Item# MDS9091818; Lot #136470

Why it was recalled

Product's non-conformity involves the integrity of the seal in the sterile packaging. It is possible that the seal on the sterile packaging has been compromised resulting in a loss of sterility of the medical device contained within.

Root cause (FDA determination)

Process control

Action the firm took

Medline Industries sent an Immediate Action Required letter dated December 14, 2016, to all affected customers with response forms via US mail, notifying them of the recall. Customers were instructed to quarantine affected product and return it to the firm. The product will be repackaged and sterilized. Customers with questions were instructed to call 866-359-1704. For questions regarding this recall call 847-643-3245.

Recalling firm

Firm: MEDLINE INDUSTRIES INC
Address: 3 Lakes Dr, Northfield, Illinois 60093-2753

Distribution

Distribution pattern: Nationwide Distribution

Timeline

Recall initiated: 2016-12-14
Terminated: 2019-07-09
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #152772. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.