Z-0657-2016Class II

FMS neXtra 3.5mm Aggressive Cutter Shaver Blades

Name: Z-0657-2016 FMS neXtra 3.5mm Aggressive Cutter Shaver Blades
Creator: DePuy Mitek, Inc., a Johnson & Johnson Co.
Published: 2015-11-20
License: https://open.fda.gov/license/

DePuy Mitek, Inc. / initiated 2015-11-20 / Terminated / root cause: manufacturing process

FDA source

DePuy Mitek, Inc., a Johnson & Johnson Co. began a recall of FMS neXtra 3.5mm Aggressive Cutter Shaver Blades; Product Code: 283315 Intended to provide controlled cutting, shaving, and abrading of tissue during... on 2015-11-20. FDA classified it as Class II and gives the reason as "Product is incorrectly labeled. The blade configuration in the affected lots does not match the description on the label". 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-0657-2016
Classification: Class II
Status: Terminated
Initiated: 2015-11-20
Posted: 2016-01-15
Terminated: 2017-04-12
Recalling firm: DePuy Mitek, Inc.
Product: FMS neXtra 3.5mm Aggressive Cutter Shaver Blades; Product Code: 283315 Intended to provide controlled cutting, shaving, and abrading of tissue during orthopedic procedures.
Product code: HRX Arthroscope
Reason for recall: Product is incorrectly labeled. The blade configuration in the affected lots does not match the description on the label.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: On November 20, 2015, customers were notified of the recall via letter. They were asked to take the following actions: Customer immediate actions: 1. Review inventory located within your facility and quarantine any products listed in this product recall notification. Please follow the instructions on the Business Reply Form to return any affected inventory located within your facility; 2. Review, complete, sign and return the attached business reply form to Elizabeth Messana ([email protected]) in accordance with the directions on the business reply form within 5 business days of receipt of this notification; 3. Forward this notice to anyone in your facility that needs to be informed; 4. If any potentially affected product has been forwarded to another facility, contact Elizabeth Messana at 508-828-3150; 5. Keep a copy of this notice.
Quantity in commerce: 45 units
Distribution: Worldwide Distribution. US states of TX, OH, MI, and ME; and the countries of FR, DE, SK, IT, NL, CH, and CZ.
Product codes and lots: Lot Number: M1505053

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0657-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0656-2016	Class II	Terminated	Voluntary: Firm initiated	2016-01-27	2016-01-15
Z-0657-2016	Class II	Terminated	Voluntary: Firm initiated	2016-01-27	2016-01-15
Z-0658-2016	Class II	Terminated	Voluntary: Firm initiated	2016-01-27	2016-01-15

Product code HRX

K041824Class IIX-Treme Arthroscopic Pump and Shaver SystemFuture Medical Systems, SA / cleared 2005-01-07

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)