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 Recall Z-2104-2017 · Posted None
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Recalling FirmMEDLINE INDUSTRIES INC
Recall StatusTerminated
Product CodeLXH
Date Initiated2016-12-14
Date Terminated2019-07-09
Product Quantity2,112 individual packs
Reason for Recall
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.
Firm Action
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.
Root Cause
Process control
Distribution Pattern
Nationwide Distribution
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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