Reported Apr 4, 2018 · Terminated
Phoenix Nail System, intended for use with an intramedullary nail system for alignment, stabilization and fixation of…
Zimmer Biomet, 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: Zimmer Biomet, Inc. · 56 E Bell Dr · Warsaw, IN · 46582-6989
Is this the product you have?
3 of 3 products
| Model / number | Product as published |
|---|---|
| — | Phoenix Nail System, intended for use with an intramedullary nail system for alignment, stabilization and fixation of fractures. 3.5mm Inserter Connector, Short |
14-441045 | — |
| — | Kit Model Numbers: 14-400082, 14-400082S, 14-440065S, 14-442000-00, 14-442000S, 14-444000-00, 979105, 14-441045-00, and 14-444000S |
- Lot codes and dates
Lots manufactured before March 302017
- Packaging Lot Numbers
244 of 244 codes
303420301890507880507930507980508010508020508030508070508080484940485380485410485420485430485440485450485460535050623990636950636960636970636980636990676570676600676610676620676630676640928320928340928370928380090570484120484230484300484320484330484370484420484440484450484490526200526210526230526250526260526270526280526290526300598480599230599240599250599260
- Laser marking on the deviceZB121001, ZB121002 ZB130902 90225701 90224951,
143 of 143 codes
90225701RS08A01490227192902271929022719290227192902271929022719290227192902271929022719290227192902271929022719290227192902271929022719290227192902271929022719290227192902271929022719290227192902271929022719290227192902271929022719290227192902271929022719290227192902271929022719290229981902271929022719290227192902271929022719290227192902271929022719290227192902271929022719290227192902271929022719290227192902271929022719290227192902271929022719290227192902271929022719290227192
ZB130901,F4C7912ZB131201ZB131001ZB160101ZB160101ZB160702ZB121101ZB121101ZB120801ZB120802ZB120802ZB120802ZB131001ZB151101ZB151101ZB161002ZB161002ZB161001ZB161002ZB130902ZB160702ZB150703F2L6299F2L6299ZB151102
ZB101201,ZB130902ZB160501ZB131201ZB131201ZB150501ZB150501ZB150501ZB150501ZB150501ZB150501ZB160501ZB141001ZB141001ZB131001ZB120201ZB160701ZB160202ZB160202ZB160201ZB131201ZB131201
ZB120802, ZB120801 90229981 ZB120201 ZB141201 ZB131001, ZB130901 ZB160502 ZB151001 3050001, 90229981 ZB151001 ZB121002, ZB121001 ZB151001 ZB120701 ZB150702 3050001 RS08C028 RS08A014, RS08A032, RS08C028,ZB101202F3L6472ZB101202ZB170201ZB101202ZB120701ZB160801ZB160801ZB150703ZB170203ZB160901ZB160901ZB160901
RS08A014, RS08A032 F4C7912 90227192 F4C7912 90227192 F4C7912 90227191, 90227192, 90229981, 90229021 F4C7912 90229981232080ZB101101ZB101201ZB11040190227191F3L6472F3L647290227192902271929022719290227192RS08A01490227192F3L6472F3L6472
- Amount recalled
- 2470
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
Certain lots of the Phoenix Tibia Nail 3.5mm Inserter instruments are being recalled due to reports of fracturing and remaining in the device implant.
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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