MEDLINE INDUSTRIES INC: 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.

Agency Publication Date: May 17, 2017

Affected Products

Product: 16 mm Distraction Pin, Titanium, 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.

Item# MDS9091616T; Lot #132638

Lot Numbers:

132638

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.

16 mm Pin: Item# MDS9091212; Lots #136469, 136754 | 18 mm Pin: Item# MDS9091818; Lot #136470

Lot Numbers:

136470

Product: 10 mm Distraction Pin, Aggressive 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.

Item# MDS9091010; Lots #133115, 136754

Product: 14 mm Distraction Pin, Exagg 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.

Item# MDS9091414A; Lots #136190

Product: 12 mm Distraction Pin, Blunt 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.

Item# MDS9091212B; Lots #136780

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 76298

Status: Resolved

Manufacturer: MEDLINE INDUSTRIES INC

Manufactured In: United States

Units Affected: 5 products (198 individual packs; 2,112 individual packs; 49 individual packs; 1031 individual packs; 300 individual packs)

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AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

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Affected Products

Item# MDS9091616T; Lot #132638

Lot Numbers:

132638

16 mm Pin: Item# MDS9091212; Lots #136469, 136754 | 18 mm Pin: Item# MDS9091818; Lot #136470

Lot Numbers:

136470

Item# MDS9091010; Lots #133115, 136754

Item# MDS9091414A; Lots #136190

Item# MDS9091212B; Lots #136780