Recall Z-1794-2021— Wishbone Medical, Inc.
Class II · Terminated
Class II FDA medical device recall by Wishbone Medical, Inc., initiated 2021-04-30, terminated 2022-07-28. It names one FDA 510(k) clearance: K180736. Product: WishBone Medical Plate and Screw System - Screw, Fixation, Bone, Washer, Bolt Nut. Part Number: PK-SMC0635NL-TI-US, PK-SMC0635NR-TI-US, PK-SMC0835NSL-TI-US, PK-SMC0835NSR-TI-US. Reason: Nonconformities were discovered to the engineering specifications for implant plates and screws..
- Recalling firm
- Wishbone Medical, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2021-04-30
- Terminated
- 2022-07-28
- Firm location
- Warsaw, IN, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
WishBone Medical Plate and Screw System - Screw, Fixation, Bone, Washer, Bolt Nut. Part Number: PK-SMC0635NL-TI-US, PK-SMC0635NR-TI-US, PK-SMC0835NSL-TI-US, PK-SMC0835NSR-TI-US
Reason for recall
Nonconformities were discovered to the engineering specifications for implant plates and screws.
Data sourced from openFDA. This site is unofficial and independent of the FDA.