FDA Medical Device Recalls (openFDA)
Orthohelix Surgical Designs Inc: 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.
- Recall number
- Z-3081-2011
- Recalling firm
- Orthohelix Surgical Designs 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.
- Status
- Terminated
- Initiated
- 2011-07-06
- Posted
- 2011-08-29
- Terminated
- 2012-09-10
- Reason
- The surgical tray does not meet our Instruction for Use (IFU) for dry time requirement.
- 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
- 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.
- Lot, serial or model codes
- 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.
- 510(k) numbers
- ["K101962"]
- PMA numbers
- not on file
- Product code
- HRS
- Firm FEI
- 3000718467
- Firm city
- Medina
- Firm state
- OH
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28