Lower riskMedical device recall · FDA · Published September 16, 2019
Synapse System 3.5mm Screws Recall: Wrong Size Risk in Spinal Surgery
Synthes recalls 3.5mm spinal screws that measure 4.0mm instead of 3.5mm. This size error could cause improper spinal fusion. Affected products include Part No. 04.615.026 sold under 10L2702.
“Synapse System 3.5mm Screws Recall: Wrong Size Risk in Spinal Surgery.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/67015-synapse-system-3-5mm-screws-recall-wrong-size-risk-in. Based on FDA recall #Z-0223-2020 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0223-2020%22&limit=1).
The FDA announced on 2019-09-16 that Synthes (USA) Products LLC voluntarily recalled Synapse System 3.5mm TI Cancellous Polyaxial Screws, Part No. 04.615.026, because the screws measure 4.0mm in diameter instead of the specified 3.5mm.
How to tell if you have it
Brand: Synthes
Product: Synapse System 3.5mm TI Cancellous Polyaxial Screws
Part No.: 04.615.026
Lot code: 10L2702
Quantity: 6 units distributed to NJ
The hazard
The recalled screws measure 4.0mm in diameter instead of 3.5mm, according to the FDA recall record.
Context
GovInfoNow's records show Synthes (USA) Products LLC has 19 other recalls on record since 2017-07-21. Other recent recalls include the Synthes 2.4V TAP CORTEX SCREW Recall on 2026-02-25, the Synthes Low Prof Locking Screw Recall on 2025-09-26, and the Synthes Stardrive Screwdrivers May Cause Surgical Delay - Recall on 2024-04-25. Other recent recalls of similar products include the Tornier Perip Screw Recall (2025-12-19), the APTUS 2.8 TriLock Screw Recall (2026-01-09), and the Prodisc C SK Product Recall (2025-12-31).
How to tell if you have this one
Check for the part number 04.615.026 on the screw packaging or label. The product was sold under the 10L2702 code for spinal surgery use.
Brand
Synthes
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Product Details
Look for the part number 04.615.026 on the screw packaging or label to confirm if it's affected.
Where it went and when
Where it was distributed
Distributed in New Jersey.
Listed by the agency
Not listed
FDA distribution: “Distributed to NJ.” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: New Jersey.
Recall timeline
FDA terminated this recall 7 months after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-0223-2020 (September 16, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0223-2020 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.