Synthes B37 Replacement Screws. M3.5 Screw for recall: Labeling Error
Synthes B37 Replacement Screws. M3.5 Screw for insertion handle guide/aiming arm, part numbers 3.113.025 and 03.113.026. Surgical instrument for use…
Why was Synthes B37 Replacement Screws. M3.5 Screw for recalled?
All lots of B37 Replacement Screws are being recalled due to potential mislabeling where the package may not contain the screws identified on the label.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
All lots of part no. B37: 6350586, 6771518, 7086318, 7386422, 7523960, and 7548937.
- Product
- Synthes B37 Replacement Screws. M3.5 Screw for insertion handle guide/aiming arm, part numbers 3.113.025 and 03.113.026. Surgical instrument for use…
- Recalling firm
- Synthes, Inc.
- Quantity
- 44
- Distribution
- Distributed US nationwide, in DC and the states of KY, PA, IL, WA, AZ, CA, OK, FL, and KS.
- Recall date
- July 9, 2014
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)