Z-3081-2011

Mini MaxLock Extreme Plating System Case & Tray, Model Number(s): MXM-901

Name: Z-3081-2011 Mini MaxLock Extreme Plating System Case & Tray, Model Number(s): MXM-901
Creator: Orthohelix Surgical Designs Inc
Published: 2011-07-06
License: https://open.fda.gov/license/

TORNIER Inc. / initiated 2011-07-06 / Terminated / root cause: manufacturing process

FDA source

Orthohelix Surgical Designs Inc began a recall of Mini MaxLock Extreme Plating System Case & Tray, Model Number(s): MXM-901, Product Usage: The Mini MaxLock Extreme Plating System is intended to stabilize and... on 2011-07-06. The reason FDA records is "The surgical tray does not meet our Instruction for Use (IFU) for dry time requirement". 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-3081-2011
Status: Terminated
Initiated: 2011-07-06
Posted: 2011-08-29
Terminated: 2012-09-10
Recalling firm: TORNIER Inc.
Product: Mini MaxLock Extreme Plating System Case & Tray, Model Number(s): MXM-901, Product Usage: The Mini MaxLock Extreme Plating System is intended to stabilize and aid in the repair of fractures, fusions, and osteotomies for small bones and bone fragments. Surgical Case and Tray Delivery System used to house plating and screw orthopedic implant system and instrumentation.
Product code: HRS Plate, Fixation, Bone
Reason for recall: The surgical tray does not meet our Instruction for Use (IFU) for dry time requirement.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: Orthohelix Surgical Designs Inc sent a RECALL NOTIFICATION letter dated July 6, 2011 and an UPDATED URGENT RECALL 2ND NOTIFICATION letter dated July 13, 2011 to all affected customers. The letter identified the recalled product, the problem, and the Field Correction actions to be taken. Customers were instructed to remove the blue rubber mat in the utility bay of the tray base immediately, tag the mat with the tray number, and return it to recalling firm immediately. The letter states once customers have removed the blue rubber mat from the tray base, they may continue to use the tray and system normally. No further actions or precautions are needed. Distributors were also asked to notify their customers of the recall. If you have any questions, please call 330-247-1444 or 330-247-1445.
Quantity in commerce: 61 trays
Distribution: USA Nationwide Distribution including the states of: AR, AZ, CA, CO, FL, GA, IL, IN, KY, MA, MD, MI, MO, NC, NE, NJ, NM, NY, OH, OR, PA, SD, TN, TX, UT, VA, WA, WI & WY.
Product codes and lots: Model Number(s): MXM-901; Tray codes affected: LAQ, LAV, LCL, LCN, LBZ, LCA, LBV, LCU, LAR, LBJ, LBT, LDE, LDG, LBL, LCD, LBI, LCI, LBQ, LCV, LBK, LBC, LCW, LCB, LDH, LBM, LCM, LCK, LDB, LBS, LCE, LDD, LDF, LAX, LDI, LAP, LBH, LBP, LAO, LBB, LBE, LBX, LCH, LAT, LAS, LCR, LDC, LAW, LCJ, LDJ, LCZ, LAU, LBF, LCQ, LBN, LCP, LCX, LBU, LBW, LBY, LCT, LCY, LAY, LAZ, LBA, LBD, LBG, LBO, LBR, LCC, LCF, LCG, LCS, LDA, LDM, LDN, LDO, LDP, LDQ, LDR, LDS, LDT, LDU & LDK.

Product code HRS

K101962Class IIMini Maxlock Extreme Plating SystemOrthohelix Surgical Designs, Inc. / cleared 2010-09-27

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)