Z-0421-2012

Maxlock Extreme Extremity Plating System with Variable Angle Technology

Name: Z-0421-2012 Maxlock Extreme Extremity Plating System with Variable Angle Technology
Creator: Orthohelix Surgical Designs Inc
Published: 2011-08-22
License: https://open.fda.gov/license/

TORNIER Inc. / initiated 2011-08-22 / Terminated / root cause: manufacturing process

FDA source

Orthohelix Surgical Designs Inc began a recall of MAXLOCK EXTREME EXTREMITY PLATING SYSTEM WITH VARIABLE ANGLE TECHNOLOGY. Product Usage: Variable Angle technology in MTP, TMT, MFT, MXL, DFX, and EDL plates... on 2011-08-22. The reason FDA records is "The firm discovered a testing protocol error, in both dynamic and static cantilever comparative testing, during the initial comparative testing". 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-0421-2012
Status: Terminated
Initiated: 2011-08-22
Posted: 2012-01-11
Terminated: 2012-02-19
Recalling firm: TORNIER Inc.
Product: MAXLOCK EXTREME EXTREMITY PLATING SYSTEM WITH VARIABLE ANGLE TECHNOLOGY. Product Usage: Variable Angle technology in MTP, TMT, MFT, MXL, DFX, and EDL plates are indicated for fractures, fusions and osteotomies for small bones in the hand, wrist, foot and ankle in both pediatric and adult patients. Variable Angle Technology in MXL and CLA plates are indicated for the fractures, fusions, and osteotomies of the clavicle and small bones in the hand, wrist, foot and ankle.
Product code: HRS Plate, Fixation, Bone
Reason for recall: The firm discovered a testing protocol error, in both dynamic and static cantilever comparative testing, during the initial comparative testing.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: Orthohelix Surgical Designs Inc. sent an URGENT RECALL NOTIFICATION letter dated August 22, 2011 to all affected customers. The letter identified the affected products, the problem, and the actions to be taken. Customers were instructed to immediately inventory, remove and return the recalled product to the firm via FedEx or any shipping method with tracking capability. Customers were also requested to notify any affected user facilities of the recall. For any questions call 330-247-1444 or 330-247-1445.
Quantity in commerce: 2,722 units
Distribution: Nationwide Distribution (USA) - including the states of: CA, CO, CT, FL, GA, IA, IL, KY, LA, MD, MI, MO, NC, NJ, NM, NY, OH, OK, PA, SD, TN, TX, UT, VA, WA, WI and WY.
Product codes and lots: Lot # 1364, 1731, 1862, Model # VAR-031-35-10, Model # VAR-031-35-12, Model # VAR-031-35-14, Model # VAR-031-35-16, Model # VAR-031-35-18, Model # VAR-031-35-20, Model # VAR-031-35-22, Model # VAR-031-35-24, Model #, VAR-031-35-26, Model # VAR-031-35-28, Model # VAR-031-35-30 & Lot # 1365011, 1365012, Model #, MXL-032-35 and Model # VAR-032-35

Product code HRS

K102156Class IIMaxlock Extreme Extremity Plating System Distal Radius Plates and ScrewsOrthohelix Surgical Designs, Inc. / cleared 2010-09-30

Process control is the most common named cause of a device recall11 SEP 2026 / by Medical Device Manufacturing

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)