Z-2104-2017Class II

16 mm [or 18 mm] Distraction Pin, Qty: 1 per pack; STERILE; Manufactured for: Medline Industries, Inc...

Name: Z-2104-2017 16 mm [or 18 mm] Distraction Pin, Qty: 1 per pack; STERILE; Manufactured for: Medline Industries, Inc...
Creator: Medline Industries Inc
Published: 2016-12-14
License: https://open.fda.gov/license/

MEDLINE INDUSTRIES, LP - Northfield / initiated 2016-12-14 / Terminated / root cause: manufacturing process

FDA source

MEDLINE INDUSTRIES INC began a recall of 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... on 2016-12-14. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2104-2017
Classification: Class II
Status: Terminated
Initiated: 2016-12-14
Posted: 2017-05-17
Terminated: 2019-07-09
Recalling firm: MEDLINE INDUSTRIES, LP - Northfield
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.
Product code: LXH Orthopedic Manual Surgical Instrument
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.
Root cause tag: manufacturing process
FDA 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 in commerce: 2,112 individual packs
Distribution: Nationwide Distribution
Product codes and lots: 16 mm Pin: Item# MDS9091212; Lots #136469, 136754 | 18 mm Pin: Item# MDS9091818; Lot #136470

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2104-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2103-2017	Class II	Terminated	Voluntary: Firm initiated	2017-05-24	2017-05-17
Z-2104-2017	Class II	Terminated	Voluntary: Firm initiated	2017-05-24	2017-05-17
Z-2105-2017	Class II	Terminated	Voluntary: Firm initiated	2017-05-24	2017-05-17
Z-2106-2017	Class II	Terminated	Voluntary: Firm initiated	2017-05-24	2017-05-17
Z-2107-2017	Class II	Terminated	Voluntary: Firm initiated	2017-05-24	2017-05-17

Product code LXH

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)