Reported Jun 13, 2018 · Terminated
Locking Screw, D 2.0MM X 8MM, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label. Size (Part Number): a) D 2.0MM X 8MM…
Orthofix, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Orthofix, Inc · 3451 Plano Pkwy · Lewisville, TX · 75056-9453
Is this the product you have?
12 of 12 products
| # | Product as published |
|---|---|
| 1 | D 2.0MM X 8MM (002-E-20008) |
| 2 | D 2.0MM X 10MM (002-E-20010) |
| 3 | D 2.0MM X 12MM (002-E-20012) |
| 4 | D 2.0MM X 14MM (002-E-20014) |
| 5 | D 2.0MM X 16MM (002-E-20016) |
| 6 | D 2.0MM X 18MM (002-E-20018) |
| 7 | D 2.0MM X 20MM (002-E-20020) |
| 8 | D 2.0MM X 22MM (002-E-20022) |
| 9 | D 2.0MM X 24MM (002-E-20024) |
| 10 | D 2.0MM X 26MM (002-E-20026) |
| 11 | D 2.0MM X 28MM (002-E-20028) |
| 12 | D 2.0MM X 30MM (002-E-20030) |
- Lot codes and dates
12 of 12 products
Products covered by this recall # Barcodes Product as published 1 18056099646161(18056099646161)B1204974, B1089899, B1201171, B1201171 2 18056099646178(18056099646178) B1195696, B1204268, B1083839 3 18056099646185(18056099646185) B1215486, B1201172, B1201172, B1204281, B1083845 4 18056099646192(18056099646192) B1215489, B1204975, B1083855, B1201173, B1201173 5 18056099646208(18056099646208) B1215482, B1204585, B1195748, B1089887 6 18056099646215(18056099646215) B1215488, B1204559, B1083856 7 18056099646222(18056099646222) B1215483, B1204558, B1083854 8 18056099646239(18056099646239) B1215490, B1204277, B1195721, B1083849 9 18056099646246(18056099646246) B1215484, B1204279, B1195703, B1089890 10 18056099646253(18056099646253) B1215491, B1204283, B1195720, B1083648 11 18056099646260(18056099646260) B1215485, B1089879, B1201174, B1204267, B1204267 12 18056099646277(18056099646277) B1215487, B1204284, B1195751, B1083857 - Amount recalled
- 870
This recall covers 20 products
The agency filed one notice per product. You are reading one of them; the other 19 are below.
7 more are in the archive.
Where it was sold
Why it was recalled
Firm is conducting a voluntary recall of the Rival Reduce Fracture Plating System and Rival View Plating System. As the result of a complaint investigation, the locking screws were confirmed to not properly engage the plates during surgery.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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