Z-1524-2016Class II

Cervical Spine Locking Plate (CSLP) System, 4mm Cancellous Self Tapping Screw, Length 16mm Lot # 9666776 and...

Name: Z-1524-2016 Cervical Spine Locking Plate (CSLP) System, 4mm Cancellous Self Tapping Screw, Length 16mm Lot # 9666776 and...
Creator: Synthes (USA) Products LLC
Published: 2016-01-06
License: https://open.fda.gov/license/

Synthes (USA) Products LLC / initiated 2016-01-06 / Terminated / root cause: packaging

FDA source

Synthes (USA) Products LLC began a recall of Cervical Spine Locking Plate (CSLP) System, 4mm Cancellous Self Tapping Screw, Length 16mm Lot # 9666776 and 4mm Cortex Standard Screw, Length 16mm Lot #... on 2016-01-06. FDA classified it as Class II and gives the reason as "DePuy Synthes is initiating a Voluntary Medical Device Recall of lot # 9666776 and 9671879 of Cancellous and Cortex 4.0 mm Screws, which are a part of the Cervical Spine Locking Plate (CSLP) System due to discovery of a...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-1524-2016
Classification: Class II
Status: Terminated
Initiated: 2016-01-06
Posted: 2016-04-20
Terminated: 2017-01-31
Recalling firm: Synthes (USA) Products LLC
Product: Cervical Spine Locking Plate (CSLP) System, 4mm Cancellous Self Tapping Screw, Length 16mm Lot # 9666776 and 4mm Cortex Standard Screw, Length 16mm Lot # 9671879
Product code: KWQ Appliance, Fixation, Spinal Intervertebral Body
Reason for recall: DePuy Synthes is initiating a Voluntary Medical Device Recall of lot # 9666776 and 9671879 of Cancellous and Cortex 4.0 mm Screws, which are a part of the Cervical Spine Locking Plate (CSLP) System due to discovery of a single lot of 450.136 screws (4mm Cancellous Self Tapping Screw, Length 16mm, lot 9666776) being swapped with a single lot of 450.016 (4mm Cortex Standard Screw, length 16 mm, lot 9671879).
Root cause tag: packaging
FDA root cause: Packaging process control
Action: DePuy Synthesis sent an Urgent Notice Medical Device Recall letter dated January 6, 2016 to customers. The letter identified the affected product, problem and actions to be taken. The letter requested customers to complete and return the attached Verification Section (page 3 of the letter). For questions call 610-719-5450 or contact your DePuy Synthes Sales Consultant.
Quantity in commerce: 30 units of Lot # 9666776 and 11 units of Lot # 9671879
Distribution: Worldwide Distribution - US Nationwide in the states of NC, CA, NY, TX, NJ, CO and the countries of: Ontario and Canada.
Product codes and lots: Lot # 9666776 (catalog ID 450.136) and 9671879 (catalog ID 450.016)

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1524-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1524-2016	Class II	Terminated	Voluntary: Firm initiated	2016-04-27	2016-04-19

Product code KWQ

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)