CLASS II Device recall · Reported 13 Nov 2019 · FDA Enforcement Report

Periarticulare Plates - Elbow, Humeral and Ulna Plates recalled

Zimmer Biomet is recalling Periarticulare Plates - Elbow, Humeral and Ulna Plates, distributed nationwide in the US. The recall was initiated on 10 Oct 2019 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesAll product manufactured prior to January 2014.

Quantity recalled5,459,583 total devices

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-0314-2020
FDA event ID: 83962
Recalling firm: Zimmer Biomet, Warsaw, IN
Classification: Class II
Status: Terminated
Recall initiated: 10 Oct 2019
FDA classified: 7 Nov 2019
Reported: 13 Nov 2019
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Packaging Defects
Device type: Other Medical Devices

Timeline

10 Oct 2019	Recall initiated by company
7 Nov 2019	Classified by FDA	+28 days
13 Nov 2019	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

Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration).

Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.

Product as listed by the FDA

Periarticulare Plates - Elbow, Humeral and Ulna Plates, Item Nos. 00234800504 00234800506 00234800508 00234800510 00234800512 00234800514 00234800604 00234800606 00234800608 00234800610 00234800612 00234800614 00234800712 00234800714 00234800716 00234800902 00234800904 00234800906 00234800908 00234800910 00234800912 00234800914 00234801002 00234801004 00234801006 00234801008 00234801010 00234801012

Where it was distributed

Distributed nationwide.

Nationwide

Questions about this recall

Why was it recalled?

Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration).

Which lots are affected?

All product manufactured prior to January 2014.

Where was it sold?

Distributed nationwide.

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

40 other products · FDA event 83962

This product is part of a recall event; the main page for the event is BF Humeral Stem, Various Sizes recalled by Zimmer Biomet.

Reported	Class	Recall	Company	Reason	Where
13 Nov 2019	CLASS II	BF Humeral Stem, Various Sizes recalled by Zimmer Biomet	Zimmer Biomet	Packaging Defects	Nationwide
13 Nov 2019	CLASS II	Connection Screw for NCB Plate recalled by Zimmer Biomet	Zimmer Biomet	Packaging Defects	Nationwide
13 Nov 2019	CLASS II	Periarticular Plates - Femur recalled by Zimmer Biomet	Zimmer Biomet	Packaging Defects	Nationwide
13 Nov 2019	CLASS II	Various Knee Systems recalled by Zimmer Biomet	Zimmer Biomet	Packaging Defects	Nationwide
13 Nov 2019	CLASS II	Prox Lat Tib Lock Plate and Dist Med Tib Lock Plate recalled	Zimmer Biomet	Packaging Defects	Nationwide
13 Nov 2019	CLASS II	Metasul Femoral Heads, various sizes recalled by Zimmer Biomet	Zimmer Biomet	Packaging Defects	Nationwide
13 Nov 2019	CLASS II	Ncb Periprosthetic, "Ncb PP Prox Fem Plate", Various sizes recalled	Zimmer Biomet	Packaging Defects	Nationwide
13 Nov 2019	CLASS II	Various temporary devices used during the implantation recalled	Zimmer Biomet	Packaging Defects	Nationwide
13 Nov 2019	CLASS II	Ceramic Femoral Heads, various sizes recalled by Zimmer Biomet	Zimmer Biomet	Packaging Defects	Nationwide
13 Nov 2019	CLASS II	Various fixation systems and accessories recalled by Zimmer Biomet	Zimmer Biomet	Packaging Defects	Nationwide
13 Nov 2019	CLASS II	Prox Lat Humeral Lock Plate recalled by Zimmer Biomet	Zimmer Biomet	Packaging Defects	Nationwide
13 Nov 2019	CLASS II	Various fixation systems and accessories recalled by Zimmer Biomet	Zimmer Biomet	Packaging Defects	Nationwide
13 Nov 2019	CLASS II	Lps-mob Art Surf Impl D recalled by Zimmer Biomet	Zimmer Biomet	Packaging Defects	Nationwide
13 Nov 2019	CLASS II	ZPLP Fibular Plate recalled by Zimmer Biomet	Zimmer Biomet	Packaging Defects	Nationwide
13 Nov 2019	CLASS II	Universal Locking Plates Sterile recalled by Zimmer Biomet	Zimmer Biomet	Packaging Defects	Nationwide
13 Nov 2019	CLASS II	Various Knee Systems for knee joint arthroplasty, knee prosthesis recalled	Zimmer Biomet	Packaging Defects	Nationwide
13 Nov 2019	CLASS II	Periarticular Plates - Tibial recalled by Zimmer Biomet	Zimmer Biomet	Packaging Defects	Nationwide
13 Nov 2019	CLASS II	Ncb-ph Plate with 4/5/7 Lock Holes recalled by Zimmer Biomet	Zimmer Biomet	Packaging Defects	Nationwide
13 Nov 2019	CLASS II	Dist Lat Fem Lck Plate Sterile recalled by Zimmer Biomet	Zimmer Biomet	Packaging Defects	Nationwide
13 Nov 2019	CLASS II	Cephalomedullary Nail (CMN), Various sizes recalled by Zimmer Biomet	Zimmer Biomet	Packaging Defects	Nationwide
13 Nov 2019	CLASS II	Various Devices for Limb salvage arthroplasty recalled by Zimmer Biomet	Zimmer Biomet	Packaging Defects	Nationwide
13 Nov 2019	CLASS II	Periarticular Plates Shoulder, Peri Prox Lat Humeral recalled	Zimmer Biomet	Packaging Defects	Nationwide
13 Nov 2019	CLASS II	NCB Straight Narrow Plate, various sizes recalled by Zimmer Biomet	Zimmer Biomet	Packaging Defects	Nationwide
13 Nov 2019	CLASS II	Femorotibial/Femoral Nail, various sizes recalled by Zimmer Biomet	Zimmer Biomet	Packaging Defects	Nationwide
13 Nov 2019	CLASS II	cable button for NCB¿ Polyaxial Locking Plate Hex Drive recalled	Zimmer Biomet	Packaging Defects	Nationwide
13 Nov 2019	CLASS II	CLS Brevius Stem Kinectiv, hip prosthesis, various sizes recalled	Zimmer Biomet	Packaging Defects	Nationwide
13 Nov 2019	CLASS II	Cable-ready Short Gtr and Cable-ready Long Gtr recalled by Zimmer Biomet	Zimmer Biomet	Packaging Defects	Nationwide
13 Nov 2019	CLASS II	Periarticular locking plate elbow-sterile recalled by Zimmer Biomet	Zimmer Biomet	Packaging Defects	Nationwide
13 Nov 2019	CLASS II	TM Ankle and Ankle Talus L/R recalled by Zimmer Biomet	Zimmer Biomet	Packaging Defects	Nationwide
13 Nov 2019	CLASS II	Metasul Taper Liner, various sizes recalled by Zimmer Biomet	Zimmer Biomet	Packaging Defects	Nationwide
13 Nov 2019	CLASS II	Various Surgical Instruments: Screws and Reamers recalled	Zimmer Biomet	Packaging Defects	Nationwide
13 Nov 2019	CLASS II	Sidus Stem-Free Shoulder Humeral Head recalled by Zimmer Biomet	Zimmer Biomet	Packaging Defects	Nationwide
13 Nov 2019	CLASS II	Peri Dist Volar/dorsal T/dorsal Delta Radial recalled by Zimmer Biomet	Zimmer Biomet	Packaging Defects	Nationwide
13 Nov 2019	CLASS II	Trabecular Metal Reverse Shoulder System recalled by Zimmer Biomet	Zimmer Biomet	Packaging Defects	Nationwide
13 Nov 2019	CLASS II	Fitmore Hip Stem, hip prosthesis, various sizes recalled	Zimmer Biomet	Packaging Defects	Nationwide
13 Nov 2019	CLASS II	Coorad Morrey Total Elbow recalled by Zimmer Biomet	Zimmer Biomet	Packaging Defects	Nationwide
13 Nov 2019	CLASS II	Various Hip Joint Replacement Systems recalled by Zimmer Biomet	Zimmer Biomet	Packaging Defects	Nationwide
13 Nov 2019	CLASS II	Various Custom Devices recalled by Zimmer Biomet	Zimmer Biomet	Packaging Defects	Nationwide
13 Nov 2019	CLASS II	Ncb Proximal Lateral Tibia, "Ncb-pt Lax Prox 3H Tibia" recalled	Zimmer Biomet	Packaging Defects	Nationwide
13 Nov 2019	CLASS II	Sm Dis Vol/dors Rad Lat Col Plate recalled by Zimmer Biomet	Zimmer Biomet	Packaging Defects	Nationwide

More recalls from Zimmer Biomet

All 873

Reported	Class	Recall	Company	Reason	Where
30 Dec 2020Device	CLASS II	Spinal Rod Cutter recalled by Zimmer Biomet	Zimmer Biomet	Other	Nationwide
23 Dec 2020Device	CLASS II	Polaris 5.5 Spinal System and Polaris 5.5/Cypher Spinal recalled	Zimmer Biomet	Device Malfunction	Nationwide
11 Nov 2020Device	CLASS II	ZCA All Longevity Crosslinked Polyethylene, I.D. recalled	Zimmer Biomet	Other	Nationwide
11 Nov 2020Device	CLASS II	ZCA All Longevity Crosslinked Polyethylene, I.D., Neutral, O.D recalled	Zimmer Biomet	Other	Nationwide
11 Nov 2020Device	CLASS II	ZCA All Longevity Crosslinked Polyethylene, I.D., Neutral, O.D recalled	Zimmer Biomet	Other	Nationwide

Other Other Medical Devices recalls

All 13,778

Reported	Class	Recall	Company	Reason	Where
16 Sep 2026Device	CLASS II	Citric Complete Dry Citric Acid Concentrate recalled	Nipro Renal Soultions USA	Other	Nationwide
16 Sep 2026Device	CLASS I	Kit: Epidural/Pain TQC 20/Cs recalled by Medical Action Industries	Medical Action Industries Inc. 306	Sterility	6 states
16 Sep 2026Device	CLASS II	Halyard IV Start Kit Non-Sterile recalled by Avid Medical	Avid Medical	Sterility	Nationwide
16 Sep 2026Device	CLASS I	Kit: Single Shot Epidural 20/Cs recalled by Medical Action Industries	Medical Action Industries Inc. 306	Sterility	6 states
16 Sep 2026Device	CLASS II	AMS Convenience Kit: Dsaek Pack - RX recalled	Windstone Medical Packaging	Device Malfunction	Nationwide