Anjon Holdings Recalls Spinal Bone Fixation Fasteners Due to Galling
Anjon Holdings is recalling 249 Anjon Bremer Molded Crown bone fixation fasteners because of a high rate of galling in a threaded component.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a mechanical defect (galling) in a spinal implant where injury has not yet been reported, fitting the 'High' severity criteria for risk-of-harm products.
Plain-English summary
Anjon Holdings is recalling 249 units of the Anjon Bremer Molded Crown bone fixation fastener, reference number 100048. These devices are smooth or threaded metallic fasteners used for spinal applications to provide cervical spine immobilization and therapeutic traction for patients with cervical trauma or other neck conditions.
The recall was initiated due to a high rate of galling of one threaded component. The affected devices were distributed worldwide, including nationwide in the United States and in Japan for training purposes. Specific lot numbers involved include 170240 for US customers and 170162, 170163, 70164, 170165, 170229, 170240, 170247, 170260, and SM 42048 for international customers.
Healthcare providers and patients should contact Anjon Holdings for further instructions regarding the return or replacement of these devices.
The recalled product
- Product
- Anjon Bremer Molded Crown. bone fixation fastener for spinal use. REF number 100048 - Product Usage: Smooth or threaded metallic bone fixation fastener. Provides cervical spine immobilization and therapeutic traction for treatment of patients with cervical trauma or other neck c
- Manufacturer
- Anjon Holdings
- Category
- Medical Device — Spinal Implant
- Hazard
- Affected units
- 249
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 (9)
- REF number 100048 Lot # 170240
- US customer Lot # 170162
- 170163
- 70164
- 170165
- 170229
- 170240
- 170247
- 170260 and SM 42048. International customers.
Distribution
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