Recalls / —
—#124768
Product
Locking Cortical Screw 3.5mmX38mm REF 8161-35-038
- FDA product code
- HRS — Plate, Fixation, Bone
- Device class
- Class 2
- Medical specialty
- Orthopedic
- 510(k) numbers
- K072083, K072832, K082300
- Affected lot / code info
- Catalog Number: 816135038 (8161-35-038) Lot Number Identification: RM244D
Why it was recalled
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.
Root cause (FDA determination)
Labeling mix-ups
Action the firm took
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.
Recalling firm
- Firm
- Biomet, Inc.
- Address
- 56 E Bell Dr, Warsaw, Indiana 46582-6989
Distribution
- Distribution pattern
- US Distribution including states of: AZ, CA, GA, IL, KY, MI, NC, NH, NY, OH, PA, SD, TX, UT, and VA.
Timeline
- Recall initiated
- 2013-12-19
- Posted by FDA
- 2014-01-10
- Terminated
- 2015-07-07
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #124768. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.