WishBone Medical Plate and Screw System Engineering Specification Nonconformity Recall
Wishbone Medical is recalling WishBone Medical Plate and Screw System implants due to nonconformities in engineering specifications. The recall affects 60 units distributed in Virginia, Pennsylvania, and Indiana.
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: FDA Class II classification indicates potential for serious injury. The recall addresses engineering specification nonconformities in orthopedic implants without reported injuries or hospitalizations, qualifying as a risk-of-harm situation where no adverse events have been reported.
Plain-English summary
Wishbone Medical, Inc. is recalling the WishBone Medical Plate and Screw System, a surgical implant system used in orthopedic procedures. The recall involves part numbers PK-SMC0635NL-TI-US, PK-SMC0635NR-TI-US, PK-SMC0835NSL-TI-US, and PK-SMC0835NSR-TI-US.
Nonconformities were discovered in the engineering specifications for the implant plates and screws. The FDA classified this as a Class II recall.
The affected products were distributed domestically in Virginia, Pennsylvania, and Indiana. Sixty units have been identified as part of this recall, spanning multiple lot numbers.
Patients who have received these implants should contact their healthcare provider immediately to discuss whether their implant may be affected and to determine appropriate follow-up care.
The recalled product
- 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
- Manufacturer
- Wishbone Medical, Inc.
- Affected units
- 60
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 (20)
- Lot Number: 20837
- 124555
- 124557
- 124558
- 124556
- 124554
- 124553
- 124552
- 124551
- 124550
- 124548
- 124547
- 124546
- 124545
- 124636
- 124634
- 124632
- 124631
- 124630
- 22571
Distribution
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