FDA Medical Device Recalls (openFDA)
MEDLINE INDUSTRIES INC: 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.
- Recall number
- Z-2103-2017
- Recalling firm
- MEDLINE INDUSTRIES INC
- 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.
- Status
- Terminated
- Initiated
- 2016-12-14
- Posted
- not on file
- Terminated
- 2019-07-09
- Reason
- 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
- Process control
- 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.
- Quantity
- 198 individual packs
- Distribution
- Nationwide Distribution
- Lot, serial or model codes
- Item# MDS9091616T; Lot #132638
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- LXH
- Firm FEI
- 1417592
- Firm city
- Northfield
- Firm state
- IL
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28