AlternatiV+ screw-in anchors recalled after reports of device failure
Aju Pharm is recalling 416 units of the AlternatiV+ Screw-In Anchor after reports of device failure including anchor breakage, bending, pull out and suture breakage.
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: Scored 3 under the risk-of-harm criterion: the record cites reported device failures including anchor breakage and pull out, with no injuries reported.
Plain-English summary
The AlternatiV+ Screw-In Anchor is being recalled by Aju Pharm Co., Ltd.
The reason given in the enforcement record is reports of device failure, including anchor breakage, anchor bending, anchor pull out, suture breakage and secondary packaging breakage.
The record lists 416 units under model numbers 20BN4753 and 20BN5503, all UDI codes and all lots. The record gives distribution as US nationwide in the states of California and Puerto Rico. The FDA has classified the action as Class II.
The record describes failures of the device itself and reports no injuries. Facilities should quarantine affected stock and follow Aju Pharm's instructions.
The recalled product
- Product
- AlternatiV+ Screw-In Anchor
- Manufacturer
- Aju Pharm Co., Ltd.
- Category
- Medical Device — Suture anchor
- Hazard
- device-failure
- anchor-breakage
- suture-breakage
- implant
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 (4)
- Model No. 20BN4753
- 20BN5503
- All UDI Codes
- All Lots.
Distribution
Distributed nationwide across the United States.
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