Z-0882-2017Class II

Dual Stylet Needle, Part Number 812-11R-15 The guide wire is passed through the cannulated handle of the Dual...

Name: Z-0882-2017 Dual Stylet Needle, Part Number 812-11R-15 The guide wire is passed through the cannulated handle of the Dual...
Creator: Amendia, Inc
Published: 2016-11-22
License: https://open.fda.gov/license/

Spinal Elements, Inc / initiated 2016-11-22 / Terminated / root cause: manufacturing process

FDA source

Amendia, Inc began a recall of Dual Stylet Needle, Part Number 812-11R-15 The guide wire is passed through the cannulated handle of the Dual Stylet Needles and pressed into the bone on 2016-11-22. FDA classified it as Class II and gives the reason as "The rods are packaged in packages with unacceptable seals. In some cases, the integrity of the seal is compromised by channels or voids". 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-0882-2017
Classification: Class II
Status: Terminated
Initiated: 2016-11-22
Posted: 2016-12-22
Terminated: 2024-02-01
Recalling firm: Spinal Elements, Inc
Product: Dual Stylet Needle, Part Number 812-11R-15 The guide wire is passed through the cannulated handle of the Dual Stylet Needles and pressed into the bone
Product code: LXH Orthopedic Manual Surgical Instrument
Reason for recall: The rods are packaged in packages with unacceptable seals. In some cases, the integrity of the seal is compromised by channels or voids.
Root cause tag: manufacturing process
FDA root cause: Employee error
Action: Amendia sent an Urgent Medical Device Recall letter dated November 22, 2016, to all affected customers. The letter requested that customers examine their inventory and quarantine the product. The letter also requested that they contact Amendia to confirm receipt of the letter and to obtain a Return Material Authorization for any product on hand. Customers with questions were instructed to call the following numbers: 770-575-5224 770-575-5236 770-575-5369 For questions regarding this recall call 404-610-7215.
Quantity in commerce: 1078 units
Distribution: Nationwide Distribution to AL, AZ, AR, CA, CO, FL, GA, IA, KS, KY, LA, MA, MI, MN, MO, NV, NJ, NC, SC, TN, TX, VA, WA, WV, WI and Puerto Rico
Product codes and lots: Part Number 812-11R-15 Lot Number 121945, 123231, 124146, 125418, 126822, 127868, 128459, 128464, 130818, 131492, 13496, 132594, 132813, 134514, 134515, 134517, 134909, 135290, 137302

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0882-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0881-2017	Class II	Terminated	Voluntary: Firm initiated	2016-12-28	2016-12-22
Z-0882-2017	Class II	Terminated	Voluntary: Firm initiated	2016-12-28	2016-12-22
Z-0883-2017	Class II	Terminated	Voluntary: Firm initiated	2016-12-28	2016-12-22

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)