CLASS II Device recall · Reported 13 Jun 2018 · FDA Enforcement Report

L-Plate, Sterile recalled by Orthofix

Orthofix is recalling L-Plate, Sterile, distributed in 19 states. The recall was initiated on 6 Apr 2018 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codes(UDI)/Lot: a) (18056099647830) B1108952; b) (18056099647847) B1108955

Quantity recalled30

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-2130-2018
FDA event ID: 79819
Recalling firm: Orthofix, Lewisville, TX
Classification: Class II
Status: Terminated
Recall initiated: 6 Apr 2018
FDA classified: 7 Jun 2018
Reported: 13 Jun 2018
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

6 Apr 2018	Recall initiated by company
7 Jun 2018	Classified by FDA	+62 days
13 Jun 2018	Published in enforcement report	+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Firm is conducting a voluntary recall of the Rival Reduce Fracture Plating System and Rival View Plating System. As the result of a complaint investigation, the locking screws were confirmed to not properly engage the plates during surgery.

Product as listed by the FDA

L-Plate, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Left or Right (Part Number): a) Left (003-E-00001L); b) Right (003-E-00001R)

Where it was distributed

U.S Consignees: NJ, FL, PA, SC, LA, VA, MN, TX, GA, DC, NV, IN, CA, MI, IL, MD, NC, OH, OK,

California District of Columbia Florida Georgia Illinois Indiana Louisiana Maryland Michigan Minnesota North Carolina New Jersey Nevada Ohio Oklahoma Pennsylvania South Carolina Texas Virginia

Questions about this recall

Why was it recalled?

Which lots are affected?

(UDI)/Lot: a) (18056099647830) B1108952; b) (18056099647847) B1108955

Where was it sold?

U.S Consignees: NJ, FL, PA, SC, LA, VA, MN, TX, GA, DC, NV, IN, CA, MI, IL, MD, NC, OH, OK,

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

19 other products · FDA event 79819

This product is part of a recall event; the main page for the event is Rival Reduce Kit Locking and Non-Locking Screw D, D, Sterile recalled.

Reported	Class	Recall	Company	Reason	Where
13 Jun 2018	CLASS II	Rival Reduce Kit Locking and Non-Locking Screw D, D, Sterile recalled	Orthofix	Other	19 states
13 Jun 2018	CLASS II	Y-Plate, Sterile recalled by Orthofix	Orthofix	Other	19 states
13 Jun 2018	CLASS II	Rival View Kit Locking and Non-Locking Screw D, D, Sterile recalled	Orthofix	Other	19 states
13 Jun 2018	CLASS II	Lapidus Plate, Sterile recalled by Orthofix	Orthofix	Other	19 states
13 Jun 2018	CLASS II	CC Plate, Sterile recalled by Orthofix	Orthofix	Other	19 states
13 Jun 2018	CLASS II	T-Plate, Sterile recalled by Orthofix	Orthofix	Other	19 states
13 Jun 2018	CLASS II	MTP Plate, Sterile recalled by Orthofix	Orthofix	Other	19 states
13 Jun 2018	CLASS II	Non-Locking Screw, Sterile recalled by Orthofix	Orthofix	Other	19 states
13 Jun 2018	CLASS II	Locking Screw, Sterile recalled by Orthofix	Orthofix	Other	19 states
13 Jun 2018	CLASS II	Non-Locking Screw, D, Sterile recalled by Orthofix	Orthofix	Other	19 states
13 Jun 2018	CLASS II	Non-Locking Screw, Sterile recalled by Orthofix	Orthofix	Other	19 states
13 Jun 2018	CLASS II	Locking Screw, D, Sterile recalled by Orthofix	Orthofix	Other	19 states
13 Jun 2018	CLASS II	H-Plate, Sterile recalled by Orthofix	Orthofix	Other	19 states
13 Jun 2018	CLASS II	Evans Plate, Sterile recalled by Orthofix	Orthofix	Other	19 states
13 Jun 2018	CLASS II	Box Plate, Sterile recalled by Orthofix	Orthofix	Other	19 states
13 Jun 2018	CLASS II	Straight Plate, Sterile recalled by Orthofix	Orthofix	Other	19 states
13 Jun 2018	CLASS II	TN Plate, Sterile recalled by Orthofix	Orthofix	Other	19 states
13 Jun 2018	CLASS II	Locking Screw, Sterile recalled by Orthofix	Orthofix	Other	19 states
13 Jun 2018	CLASS II	Rival Reduce Kit Plates, Sterile recalled by Orthofix	Orthofix	Other	19 states

More recalls from Orthofix

All 65

Reported	Class	Recall	Company	Reason	Where
25 Jun 2025Device	CLASS II	REF: 99-709245, Fitbone Trochanteric Nail L245mm, D9mm, Sterile recalled	Orthofix	Other	N/A
20 Nov 2019Device	CLASS II	Orthofix Catalogue Number: ref: 99-91647, US Xcaliber Ankle Complete recalled	Orthofix	Device Malfunction	29 states
20 Nov 2019Device	CLASS II	Orthofix Catalogue Number: ref 1-1100301,Drill BIT Diameter recalled	Orthofix	Device Malfunction	29 states
20 Nov 2019Device	CLASS II	Orthofix Catalogue Number: ref: 99-93501US, Pelvis Sterile KIT, RX recalled	Orthofix	Device Malfunction	29 states
20 Nov 2019Device	CLASS II	Orthofix Catalogue Number: ref: 99-92503, Prefix II Diaphyseal recalled	Orthofix	Device Malfunction	29 states

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All 13,778

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16 Sep 2026Device	CLASS II	AMS Convenience Kit: Dsaek Pack - RX recalled	Windstone Medical Packaging	Device Malfunction	Nationwide