Reported Jun 3, 2020 · Terminated
JOURNEY II UNI RESECTION PREP TRIAL, RIGHT MEDIAL/ LEFT LATERAL - Product Usage
Smith & Nephew, 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: Smith & Nephew, Inc. · 1450 E Brooks Rd · Memphis, TN · 38116-1804
Is this the product you have?
JOURNEY II UNI RESECTION PREP TRIAL, RIGHT MEDIAL/ LEFT LATERAL - Product Usage
10 of 10 products
| Model / number | Product as published |
|---|---|
74035831 | SIZE 2, CATALOG NUMBER |
74035832 | SIZE 3, CATALOG NUMBER |
74035833 | SIZE 4, CATALOG NUMBER |
74035834 | SIZE 5, CATALOG NUMBER |
74035835 | SIZE 6, CATALOG NUMBER |
74035836 | SIZE 7, CATALOG NUMBER |
74035837 | SIZE 8, CATALOG NUMBER |
74035838 | SIZE 9, CATALOG NUMBER |
74035839 | SIZE 10, CATALOG NUMBER |
74035840 | — |
- Lot codes and dates
11 of 11 products
Products covered by this recall # Product as published 1 SIZE 1, CATALOG NUMBER: REF 74035831 2 LOT/BATCH CODES: 19FM01064R, 19HM18082, 19HM21871, 19JM18534, 19JM21086, 19KM07281, 19KM15577 SIZE 2, CATALOG NUMBER: REF 74035832 3 LOT/BATCH CODES: 19EM21587R, 19FM11181R, 19HM21899, 19HM21902, 19HM21903, 19JM21089 SIZE 3, CATALOG NUMBER: REF 74035833 4 LOT/BATCH CODES: 19GM21768, 19HM18085, 19HM18085A, 19JM09477, 19JM18537, 19JM18540, 19JM18541, 19JM18542, 19JM18542A SIZE 4, CATALOG NUMBER: REF 74035834 5 LOT/BATCH CODES: 19FM11183R, 19JM07474, 19JM11137, 19JM21090, 19KM21513 SIZE 5, CATALOG NUMBER: REF 74035835 6 LOT/BATCH CODES: 19FM01065R, 19HM18086, 19HM18086A, 19HM18088, 19JM18491, 19JM21091, 19KM15580 SIZE 6, CATALOG NUMBER: REF 74035836 7 LOT/BATCH CODES: 19FM11184R, 19GM21778, 19JM07477, 19JM21093 SIZE 7, CATALOG NUMBER: REF 74035837 8 LOT/BATCH CODES: 19FM11185A, 19FM11185R, 19HM19006, 19JM21096, 19KM21504, 19KM21506, 19KM21509 SIZE 8, CATALOG NUMBER: REF 74035838 9 LOT/BATCH CODES: 19FM11191R, 19FM11191S, 19HM18091, 19HM21040, 19JM18543, 19JM21097, 19JM23714, 19KM15583 SIZE 9, CATALOG NUMBER: REF 74035839 10 LOT/BATCH CODES: 19FM05578R, 19HM18096, 19HM19658, 19KM05613, 19KM15584, 19KM15586 SIZE 10, CATALOG NUMBER: REF 74035840 11 LOT/BATCH CODES: 19HM18107, 19HM19004, 19JM23666, 19JM23674, 19JM23678, 19JM23678A, 19JM23680, 19KM12708 - Amount recalled
- 195 units
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
- Nationwide
Why it was recalled
The spike rail was manufactured with an oversized thru-hole which could potentially cause the dowel pin to fall out and the device to disassemble.
This product could cause temporary or reversible health problems — stop using it.
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