CLASS II ONGOING Device recall · Reported 9 Feb 2022 · FDA Enforcement Report
Integra Surfix Alpha Screwdriver Torx recalled by Smith & Nephew
Smith & Nephew is recalling Integra Surfix Alpha Screwdriver Torx 10, distributed nationwide in the US. The recall was initiated on 4 Jan 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-0548-2022
- FDA event ID
- 89382
- Recalling firm
- Smith & Nephew, Memphis, TN
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 4 Jan 2022
- FDA classified
- 1 Feb 2022
- Reported
- 9 Feb 2022
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Device type
- Other Medical Devices
Timeline
| 4 Jan 2022 | Recall initiated by company | |
| 1 Feb 2022 | Classified by FDA | +28 days |
| 9 Feb 2022 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
The affected screwdrivers are out of specification and may not mate with the Surfix Alpha Lock screw
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
INTEGRA SURFIX ALPHA Screwdriver Torx 10, REF 219 135 ND
Where it was distributed
US Nationwide distribution in the states of CA and OH.
Questions about this recall
Is Integra Surfix Alpha Screwdriver Torx 10 recalled?
Yes. Smith & Nephew recalled Integra Surfix Alpha Screwdriver Torx 10 on 4 Jan 2022. The recall is Class II and its status is Ongoing. Recall number Z-0548-2022.
Why was it recalled?
The affected screwdrivers are out of specification and may not mate with the Surfix Alpha Lock screw
Which lots are affected?
UDI: (01)10381780052234 (11)21101 (10)FVRG, Batch Numbers: FTL9, FTLA, and FVRG
Where was it sold?
US Nationwide distribution in the states of CA and OH.
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.
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