CLASS II ONGOING Device recall · Reported 19 Jul 2023 · FDA Enforcement Report

REF: 218-1604, 1.6mm x 4mm Profile Zero Auto-Drive Screw, Rx Only recalled

Osteomed is recalling REF: 218-1604, 1.6mm x 4mm Profile Zero Auto-Drive Screw, Rx Only, distributed nationwide in the US. The recall was initiated on 31 May 2023 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot # 1177027, 1177718, 1177812 / UDI-DI: (01)00845694034258

Quantity recalledN/A

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-2107-2023
FDA event ID: 92479
Recalling firm: Osteomed, Addison, TX
Classification: Class II
Status: Ongoing
Recall initiated: 31 May 2023
FDA classified: 7 Jul 2023
Reported: 19 Jul 2023
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Sterility
Device type: Other Medical Devices

Timeline

31 May 2023	Recall initiated by company
7 Jul 2023	Classified by FDA	+37 days
19 Jul 2023	Published in enforcement report	+12 days

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

Reason for recall

Screws for osteotomies have contain an undersize screwhead which has the potential to pass through the plate hole.

A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.

Product as listed by the FDA

REF: 218-1604, 1.6mm x 4mm Profile Zero Auto-Drive Screw, Rx Only, Sterile

Where it was distributed

Worldwide - US Nationwide distribution in the states of AZ, CA, FL, GA, KS, KY, MD, MO, MT, NE, NY, TN, TX and the country of SG.

Nationwide Arizona California Florida Georgia Kansas Kentucky Maryland Missouri Montana Nebraska New York Tennessee Texas

Questions about this recall

Is REF: 218-1604, 1.6mm x 4mm Profile Zero Auto-Drive Screw, Rx Only recalled?

Yes. Osteomed recalled REF: 218-1604, 1.6mm x 4mm Profile Zero Auto-Drive Screw, Rx Only on 31 May 2023. The recall is Class II and its status is Ongoing. Recall number Z-2107-2023.

Why was it recalled?

Screws for osteotomies have contain an undersize screwhead which has the potential to pass through the plate hole.

Which lots are affected?

Lot # 1177027, 1177718, 1177812 / UDI-DI: (01)00845694034258

Where was it sold?

Worldwide - US Nationwide distribution in the states of AZ, CA, FL, GA, KS, KY, MD, MO, MT, NE, NY, TN, TX and the country of SG.

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

More recalls from Osteomed

All 15

Reported	Class	Recall	Company	Reason	Where
19 Jul 2023Device	CLASS II	REF 218-1604-SP-10, Profile 0 4mm AutoDrive Screw Sterile Qty 10, Rx recalled	Osteomed	Sterility	Nationwide
15 Dec 2021Device	CLASS II	OsteoPower Power Console: -OsteoMed OsteoPower Power Console recalled	Osteomed	Other	Nationwide
10 Jun 2020Device	CLASS II	Osteovationex 3cc Impactformula recalled by Osteomed	Osteomed	Device Malfunction	Nationwide
10 Jun 2020Device	CLASS II	Osteovationex 5cc Impactformula recalled by Osteomed	Osteomed	Device Malfunction	Nationwide
10 Jun 2020Device	CLASS II	Osteovation 3cc Impactformula recalled by Osteomed	Osteomed	Device Malfunction	Nationwide

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