CLASS II ONGOING Device recall · Reported 8 Feb 2023 · FDA Enforcement Report
Medline Unite Foot & Ankle Screw, Polyaxial Locking recalled
Medline Industries LP - Northfield is recalling Medline Unite Foot & Ankle Screw, Polyaxial Locking, Mini T8 (2.0x8mm), distributed nationwide in the US. The recall was initiated on 22 Dec 2022 and the FDA has classified it as Class II.
Check your package
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-1046-2023
- FDA event ID
- 91491
- Recalling firm
- Medline Industries LP - Northfield, Northfield, IL
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 22 Dec 2022
- FDA classified
- 1 Feb 2023
- Reported
- 8 Feb 2023
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Other Medical Devices
Timeline
| 22 Dec 2022 | Recall initiated by company | |
| 1 Feb 2023 | Classified by FDA | +41 days |
| 8 Feb 2023 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
The recall is due to observed intra-operative screw failure. When pre-drilled with ¿1.3mm drill bit for ¿2.0mm screws and ¿1.6mm drill bit for ¿2.4mm we have observed screw failure due to excessive torque.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
MEDLINE UNITE FOOT & ANKLE Screw, Polyaxial Locking, Mini T8 (2.0x8mm), REF MMSL2008
Where it was distributed
US Nationwide distribution.
Questions about this recall
Why was it recalled?
The recall is due to observed intra-operative screw failure. When pre-drilled with ¿1.3mm drill bit for ¿2.0mm screws and ¿1.6mm drill bit for ¿2.4mm we have observed screw failure due to excessive torque.
Which lots are affected?
GTIN 10193489120707, Lot Number 810304
Where was it sold?
US Nationwide distribution.
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
2 other products · FDA event 91491This product is part of a recall event; the main page for the event is Medline Unite Foot & Ankle Drill Bit Solid Core recalled.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Medline Unite Foot & Ankle Drill Bit Solid Core recalled | Medline Industries LP - Northfield | Device Malfunction | Nationwide | |
| CLASS II | Medline Unite Foot & Ankle Screw, Non-Locking, Mini T8 (2.0x8mm) recalled | Medline Industries LP - Northfield | Device Malfunction | Nationwide |
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|---|---|---|---|---|---|
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