Locking Cortical Screw 3.5mmX38mm REF 8161-35-038
FDA device recall Z-0716-2014 · posted 2014-01-10 · Terminated
Recall details
- Recalling firm
- Biomet, Inc.
- Reason for recall
- 3.5mmx38mm Locking Cortical Screw, implants are being recalled since an investigation identified that a 3.5mmx28mm Cortical Locking Screw is labeled as a 3.5mmx38mm Cortical Locking Screw.
- Action taken
- URGENT MEDICAL DEVICE RECALL notices were sent to all consignees on December 19, 2013. Distributors who have affected hospitals in their regions were notified and provided with a copy of the notice that went to each hospital. Consignees are being contacted on an individual basis in an attempt to reconcile the product 100%. Fax back forms were provided to all consignees in order for Biomet to track returns. Non-responders will be contacted on an individual basis.
- Root cause
- Labeling mix-ups
- Status
- Terminated
- Product code
- HRS
- Quantity affected
- 52
- Distribution
- US Distribution including states of: AZ, CA, GA, IL, KY, MI, NC, NH, NY, OH, PA, SD, TX, UT, and VA.
- Date initiated
- 2013-12-19
- Date posted
- 2014-01-10
- Date terminated
- 2015-07-07
- Location
- Warsaw, IN
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ANATOMIC LOCKING PLATING SYSTEM (K082300) | DePuy Orthopaedics, Inc. | 2009-02-18 |
| ANTEROLATERAL AND MEDIAL LOCKING PLATING SYSTEM (K072832) | DePuy Orthopaedics, Inc. | 2007-12-14 |
| SMALL FRAGMENT LOCKING PLATING SYSTEM (K072083) | DePuy Orthopaedics, Inc. | 2007-10-25 |