Atlas Spine Recalls Apelo Modular Screwdriver Due to Tip Breakage
Atlas Spine, Inc. is recalling the Apelo Modular Screwdriver because the tip may break and become implanted in the body or delay surgery.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall involves a medical device where a component breakage could result in a foreign object being implanted in the body, which constitutes a significant injury risk under the rubric for Severe recalls.
Plain-English summary
Atlas Spine, Inc. is recalling the Apelo Modular Screwdriver, a component of the Apelo Pedicle Screw System Instrumentation. The recall was initiated due to complaints that the tip of the screwdriver may break.
If the tip fractures inside the modular screw, it could become implanted in the patient's body. Alternatively, if the entire screw is removed, the breakage could cause a delay in the surgery. The affected products were distributed to the state of Florida only.
Healthcare providers and patients should stop using the recalled Apelo Modular Screwdriver. The specific product is identified by PN# 70175-001, CAT#2006-41-0000, and Lot # 00686.
The recalled product
- Product
- Apelo Modular Screwdriver labeled in part: "APELO PEDICLE SCREW SYSTEM***Modular Screwdriver***Atlas Spine, Inc.***www.AtlasSpine.com*** 1555 Jupiter Park Drive #4***Jupiter, Florida 33458***561-741-1108***Tissue Sleeve***MFG Date: XX/XX/XXXX***Lot #: XXXX***Weldment***MFG Date…
- Manufacturer
- Atlas Spine, Inc.
- Affected units
- 4
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- PN# 70175-001 CAT#2006-41-0000 Lot # 00686
Distribution
Distributed in 1 state:
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