Z-0062-2015Class II

MaxLock Extreme Mod-Foot Concave Reamer; Individually packaged in a 3 x 4 bag and heat sealed with label on...

Name: Z-0062-2015 MaxLock Extreme Mod-Foot Concave Reamer; Individually packaged in a 3 x 4 bag and heat sealed with label on...
Creator: Orthohelix Surgical Designs Inc
Published: 2014-09-19
License: https://open.fda.gov/license/

TORNIER Inc. / initiated 2014-09-19 / Terminated / root cause: design

FDA source

Orthohelix Surgical Designs Inc began a recall of MaxLock Extreme Mod-Foot Concave Reamer; Individually packaged in a 3 x 4 bag and heat sealed with label on the outside. Used during procedures to clear away... on 2014-09-19. FDA classified it as Class II and gives the reason as "Incorrect sizing was being laser etched on the MaxLock Extreme Mod-Foot Concave Reamer". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0062-2015
Classification: Class II
Status: Terminated
Initiated: 2014-09-19
Posted: 2014-10-10
Terminated: 2016-10-31
Recalling firm: TORNIER Inc.
Product: MaxLock Extreme Mod-Foot Concave Reamer; Individually packaged in a 3 x 4 bag and heat sealed with label on the outside. Used during procedures to clear away bone and cartilage within the desired implant area.
Product code: LXH Orthopedic Manual Surgical Instrument
Reason for recall: Incorrect sizing was being laser etched on the MaxLock Extreme Mod-Foot Concave Reamer
Root cause tag: design
FDA root cause: Device Design
Action: An Urgent - Medical Device Recall customer notification, dated September 19, 2014, was sent out via email and FEDEx to all distributors with instructions on returning the product. The letter identified the affected product and the reason for the recall. Customers are to immediately cease distribution of the affected product, and complete and return the questionnaire. The letter also states that the recalled product will be replaced. Questions are to be directed to the Customer Service Department 1-888-494-7950.
Quantity in commerce: 38
Distribution: USA Distribution -- in the states of WI, NM, TX, WA, MO, OH, UT, TN, MI, VA, NC, VA, and PA.
Product codes and lots: Part Number: MFT-074-CC-24; Lot: 3164011

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0062-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0062-2015	Class II	Terminated	Voluntary: Firm initiated	2014-10-15	2014-10-09

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)