medical MODERATE Updated 2026-07-29

SEASPINE ORTHOPEDICS CORPORATION recalls SeaSpine Polyaxial Head REF Number: 41-3010

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Recalled Product

SeaSpine Polyaxial Head REF Number: 41-3010

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Hazard / Issue

Due to manufacturing error, polyaxial head may popoff from the screw intraoperatively following insertion.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: UDI: 10889981155117; Affected Lots: AW199682G, AW199684G.

✅ What Should You Do?

  1. 1Contact your healthcare provider immediately to discuss this recall.
  2. 2Stop using the device if it is safe to do so, and contact your provider.
  3. 3Follow the manufacturer's remedy instructions provided in the recall notice.
  4. 4Report device problems to FDA MedWatch or call 1-800-FDA-1088.

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Search Amazon for SeaSpine Polyaxial Head →

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View official government recall

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