Device recall: Synthes Matrix Mandible Short Cut Plate Cutter Synthes Matrix Mandible Short Cut Plate Cutter is intended for oral, maxi

FDA enforcement event 68111 · Class II · initiated 22 Apr 2014 · status Terminated · terminated 10 Sep 2015

DeviceVoluntary: Firm initiated1 product recordWest Chester, PA

Synthes, Inc. (West Chester, PA) initiated this device recall on 22 Apr 2014; FDA lists 1 product record under event 68111, classified Class II.

FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 91% of the 1,176 device enforcement events initiated in 2014 carry the same class.

Status: Terminated, terminated 10 Sep 2015. Initiation: voluntary: firm initiated. Synthes, Inc. has 39 enforcement events on this register, with a median of 1 product record per event.

Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.

Recalling firm

Synthes, Inc., West Chester, PA.

Reason for recall

"It was discovered internally that the face of the Synthes Matrix Mandible Short Cut Plate Cutter has the potential for discoloration/corroded material in the affected lot."

Distribution

"US Distribution including the states of CA, CT, FL, GA, NY, SD and TX."

Product records

Recall number	Product	Quantity	Class	Status	Report date
Z-1781-2014	Synthes Matrix Mandible Short Cut Plate Cutter Synthes Matrix Mandible Short Cut Plate Cutter is intended for oral, maxillofacial surgery.	14	Class II	Terminated	18 Jun 2014

Context

91%of 2014 device events are Class II1,176 events that year

1product record in this eventfirm median: 1

39events on this register for the firm

Other enforcement events for Synthes, Inc.

Initiated	Product (first record)	Type	Class	Records
18 Jun 2020	MatrixNEURO Screws - Product Usage: The intended use for this device is in fixation of cranial bones and facial skeleton	Device	Class II	1
16 Dec 2019	2.4MM TI VA LOCKING SCREW STARDRIVE 10MM STERILE, Part Number 04.210.110TS - Product Usage:Sterile Tube Packaging is a p	Device	Class II	5
19 Mar 2018	Stem Extractor f/Guide Bar, Part number 03.401.072. Instrumentation for extraction and revision of Epoca shoulder implan	Device	Class II	1
5 Mar 2018	Flex Arm Product Usage: The Synthes Flex Arm is a component of the Synthes Minimally Invasive Support System, which prov	Device	Class II	1
7 Aug 2017	LCP Drill Sleeve 1.5 Drill Bit 1.1mm Part Number 03.114.001 Used in LCP Modular Mini Fragment System, for fixation of sm	Device	Class II	1
3 Jun 2015	TITANIUM END CAP WITH T40 STARDRIVE RECESS, 0MM EXTENSION FOR TITANIUM TIBIAL NAILS-EX; Synthes Tibial Nail System EX is	Device	Class II	1
28 May 2015	Reamer / Irrigator / Aspirator (RIA): RIA Drive Shafts, RIA Tube Assemblies, sterile, RIA Reamer Head, sterile (12.0mm-1	Device	Class II	1
28 May 2015	Pull Reduction Device For 4.3mm Percutaneous Drill Guide; The pull reduction device with quick coupling is placed throug	Device	Class II	1
27 May 2015	DePuy Synthes 6.5 mm Titanium Recon Screws w/T25 Stardrive (70mm, 75mm, 80mm, 85mm, 90mm, 95mm, 105mm); part of the Expe	Device	Class II	1
13 May 2015	3.2 mm Cannulated Drill Bit/ QC 170 mm 2.7 Cannulated Drill Bit/ QC 160 mm 2.0 mm Cannulated Drill Bit / QC 150 mm there	Device	Class II	1

All 39 events for Synthes, Inc.

Questions and answers

Why was this device recalled?

FDA's record gives the reason for recall as: "It was discovered internally that the face of the Synthes Matrix Mandible Short Cut Plate Cutter has the potential for discoloration/corroded material in the affected lot."

What does Class II mean?

FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.

Where was the product distributed?

FDA's distribution pattern field reads: "US Distribution including the states of CA, CT, FL, GA, NY, SD and TX."

Is the recall still ongoing?

FDA lists the status as Terminated; the termination date is 10 Sep 2015. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.

Where does this data come from?

openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.

Provenance

Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.