RapidFire Clip recall: Sterility Concern
RapidFire Clip, Item Number 95-0154 - Product Usage: Fixation of Craniofacial bone.
Why was RapidFire Clip recalled?
Specific lots of multiple sterile medical devices may have a breach in the sterile seal. A breach in the packaging seal could lead to loss of sterility of the device.
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?
Lots 080580 231760 359160 359170 381910 382870 382900 382970 383010
- Product
- RapidFire Clip, Item Number 95-0154 - Product Usage: Fixation of Craniofacial bone.
- Recalling firm
- Biomet, Inc.
- Quantity
- 7428
- Distribution
- Worldwide distribution. US nationwide, ARGENTINA, AUSTRALIA, Brazil, CANADA, CHILE, CHINA, COSTA RICA, EMEA, HONG KONG, INDIA, JAPAN, KOREA, MALAYSIA, NEW ZEALAND, SINGAPORE, and TAIWAN
- Recall date
- December 23, 2020
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)