CLASS II Device recall · Reported 3 Oct 2018 · FDA Enforcement Report

HipLOC Hip Fracture Fixation System- Hiploc System 130¿ recalled

Biomet UK is recalling HipLOC Hip Fracture Fixation System- Hiploc System 130¿ Plate Barrel 4 Hole Plate, distributed nationwide in the US. The recall was initiated on 9 Aug 2018 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot Number: 3222008

Quantity recalled1 unit

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-3261-2018
FDA event ID: 80921
Recalling firm: Biomet UK, Bridgend
Classification: Class II
Status: Terminated
Recall initiated: 9 Aug 2018
FDA classified: 27 Sep 2018
Reported: 3 Oct 2018
Type: Voluntary: Firm initiated
Customers notified by: Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Reason category: Other Reasons
Device type: Hip & Knee Implants

Timeline

9 Aug 2018	Recall initiated by company
27 Sep 2018	Classified by FDA	+49 days
3 Oct 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

HipLOC System Plate Barrel due to an undersized bore on the HipLOC plate barrel, can result in the lag screw not fitting through the barrel

Product as listed by the FDA

HipLOC Hip Fracture Fixation System- Hiploc System 130¿ Plate 38 mm Barrel 4 Hole Plate Item Number: 2110-130-004 Product Usage: The HipLOC Compression Hip Screw may be used primarily for fixation of bone fractures. Specific indications include open reduction and internal fixation of a wide variety of fractures of the proximal femur: intracapsular fractures, intertrochanteric fractures and subtrochanteric fractures

Where it was distributed

US Nationwide in the states of AZ, MO, NJ and NM

Nationwide Arizona Missouri New Jersey New Mexico

Questions about this recall

Why was it recalled?

HipLOC System Plate Barrel due to an undersized bore on the HipLOC plate barrel, can result in the lag screw not fitting through the barrel

Which lots are affected?

Lot Number: 3222008

Where was it sold?

US Nationwide in the states of AZ, MO, NJ and NM

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

3 other products · FDA event 80921

This product is part of a recall event; the main page for the event is HipLOC Hip Fracture Fixation System-Hiploc System 135¿ recalled.

Reported	Class	Recall	Company	Reason	Where
3 Oct 2018	CLASS II	HipLOC Hip Fracture Fixation System-Hiploc System 135¿ recalled	Biomet UK	Other	Nationwide
3 Oct 2018	CLASS II	HipLOC Hip Fracture Fixation System-Hiploc System 140¿ recalled	Biomet UK	Other	Nationwide
3 Oct 2018	CLASS II	HipLOC Hip Fracture Fixation System-Hiploc System 135¿ recalled	Biomet UK	Other	Nationwide

More recalls from Biomet UK

All 4

Reported	Class	Recall	Company	Reason	Where
3 Oct 2018Device	CLASS II	HipLOC Hip Fracture Fixation System-Hiploc System 135¿ recalled	Biomet UK	Other	Nationwide
3 Oct 2018Device	CLASS II	HipLOC Hip Fracture Fixation System-Hiploc System 140¿ recalled	Biomet UK	Other	Nationwide
3 Oct 2018Device	CLASS II	HipLOC Hip Fracture Fixation System-Hiploc System 135¿ recalled	Biomet UK	Other	Nationwide

Other Hip & Knee Implants recalls

All 3,097

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26 Aug 2026Device	CLASS II	Arvis Surgical Navigation System Gen recalled by Kico Knee Innovation	Kico Knee Innovation	Device Malfunction	19 states
26 Aug 2026Device	CLASS II	Veritas Standard Reverse Total Shoulder Veritas Standard recalled	restor3d	Device Malfunction	Nationwide
19 Aug 2026Device	CLASS II	Endo-Model, Replacement Set, Tibial Plateau, right/left, L, Uhmwpe recalled	Waldemar Link GmbH & Co. KG (Mfg Site)	Other	IN
12 Aug 2026Device	CLASS II	U2 Total Knee System Femoral offset bushing recalled	United Orthopedic	Device Malfunction	Nationwide