Cortical Pin 2.0 mm,Sterile, FREEZE DRIED: Store at ambient temperature. Do Not freeze.
FDA device recall Z-2210-2015 · posted 2015-07-24 · Terminated
Recall details
- Recalling firm
- Musculoskeletal Transplant Foundation, Inc.
- Reason for recall
- Musculoskeletal Transplant Foundation (MTF) is recalling one lot of MTF's Allograft Cortical Pins because the lot was labeled as a 2.0 mm diameter pin and it may contain a 2.4 mm diameter pin.
- Action taken
- Musculoskeletal Transplant Foundation initiated this recall by either telephoning their customers or by sending a recall letter dated 5/27/15 to the customer.
- Root cause
- Labeling mix-ups
- Status
- Terminated
- Product code
- JDW
- Quantity affected
- 22 units
- Distribution
- Distributed in the states of AZ, CO, MI, MN, NC, OH and TX.
- Date initiated
- 2015-05-27
- Date posted
- 2015-07-24
- Date terminated
- 2015-12-17
- Location
- Edison, NJ
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ALLOFIX ANCHOR, 5.0 MM ANCHOR (K061498) | Musculoskeletal Transplant Foundation | 2006-07-06 |