Optilock, Locking Screw 3.5 mm x 28 mm, non sterile, REF 37728, Biomet Trauma Parsippany, NJ 97054. Cortical Locking Scr
FDA device recall Z-1439-2012 · posted 2012-04-19 · Terminated
Recall details
- Recalling firm
- Biomet, Inc.
- Reason for recall
- Biomet initiated this action after a complaint was received that item 36728, Non-Locking Screw 3.5mm x 28mm was in a package labeled as 37728, Locking Screw 3.5mm x 28mm.
- Action taken
- A March 15 2012 Urgent Medical Device Recall Notice was sent to Distributors, Operating Room Managers, and Physicians with directions to locate and remove recalled items with instructions to provide the recall notice to any sub-accounts. The letter also identified the affected product and explained the reason for the recall. OR Managers and Physicians are to confirm recall notice receipt by calling 800-348-9500, extention 3983 or 3009 and make arrangements for product return. Distributors are to complete and FAX back the response tracking form to the attention of Angi Dickson, Biomet @ 574-372-1638. Questions should be directed to 574-372-3983 or 574-371-3009 M- F, 8 AM- 5 PM, (ET).
- Root cause
- Labeling mix-ups
- Status
- Terminated
- Product code
- HRS
- Quantity affected
- 45
- Distribution
- Worldwide Distribution -- USA, including NJ, TX, VA, MI IL, KT, & Puerto Rico, and country of the Netherlands.
- Date initiated
- 2012-03-15
- Date posted
- 2012-04-19
- Date terminated
- 2013-08-29
- Location
- Warsaw, IN
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| EBI OPTILOCK UPPER EXTREMITY PLATING SYSTEM (K062494) | Ebi, L.P. | 2006-10-19 |