Hybrid suture anchors recalled after reports of breakage and pull out
Aju Pharm is recalling 233 units of the Fixone Hybrid Anchor after reports of device failure including anchor breakage, bending, pull out and suture breakage.
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 3/5 (High).
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 Fixone Hybrid 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 233 units under model numbers KAPN-47501nc, KAPN-55001c, KAPN-55001na and KAPN-55001nc, 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
- MR 7700. Product Code (REF): (1) 782120, (2) 782153. MR systems with SW version R11.1 and R12.1.
- Manufacturer
- Philips North America
- Category
- Medical Device — Suture anchor
- Affected units
- 9
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 (12)
- MR systems with SW version R11.1 and R12.1. (1) Product Code (REF): 782120
- UDI-DI: 00884838104112
- Serial Numbers: 65019
- 65060
- 65066
- 65065
- 65051
- 65038
- 65005. (2) Product Code (REF): 782153
- UDI-DI: 00884838112858
- Serial Numbers: 68010
- 68017.
Distribution
Part of a larger recall action
This product is one of 13 recalled by Philips North America under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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