CLASS II ONGOING Device recall · Reported 27 Dec 2023 · FDA Enforcement Report
LITe Decompression Snake Arm recalled by Stryker Spine
Stryker Spine is recalling LITe Decompression Snake Arm, distributed in Maryland, Michigan, New Mexico, Texas. The recall was initiated on 1 Nov 2023 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-0610-2024
- FDA event ID
- 93573
- Recalling firm
- Stryker Spine, Allendale, NJ
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 1 Nov 2023
- FDA classified
- 21 Dec 2023
- Reported
- 27 Dec 2023
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 1 Nov 2023 | Recall initiated by company | |
| 21 Dec 2023 | Classified by FDA | +50 days |
| 27 Dec 2023 | 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
Product arm was manufactured with the incorrect clamp component. As a result, the affected product arm cannot attach to the arm post shaft.
Product as listed by the FDA
LITe Decompression Snake Arm, REF 48080230
Where it was distributed
US: MD, MI, NM, TX & OUS: Canada & France.
Questions about this recall
Why was it recalled?
Product arm was manufactured with the incorrect clamp component. As a result, the affected product arm cannot attach to the arm post shaft.
Which lots are affected?
UDI-DI (GTIN): 07613327263909, lot # 227764.
Where was it sold?
US: MD, MI, NM, TX & OUS: Canada & France.
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.
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