TANDEM — Class II medical device recall Z-0351-2017
Terminated recall by Smith & Nephew, Inc., reported 2016-11-09, distributed nationwide. Some Bipolar shells were manufactured with an out of specification retainer groove.
| Recall number | Z-0351-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Smith & Nephew, Inc., Memphis, TN, United States |
| Recall initiated | 2016-08-29 |
| Classified | 2016-11-03 |
| Reported by FDA | 2016-11-09 |
| Terminated | 2019-08-16 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AU, BE, CA, CH, CN, CY, DE, ES, FR, IN, IT, JP, KR, MX, NL, PL, PT, SG, TH, TR, ZA |
| Quantity | 5,806 units |
| Reason classes | specification failure |
| Serial numbers | 13KM09768, 13KM20614A, 13KM20615, 13KM22761A, 13KM22761B, 13KM22761C, 13KM22762, 13KM22764, 13KM24091, 13KM24092, 13KM24093, 13KM24095, 13KM24095A, 13KM24097, 13KM24099, 13LM00813, 13LM00822, 13LM00828, 13LM00831, 13LM00899, 13LM00900, 13LM01891, 13LM01892, 13LM01893, 13LM01894 and 475 more |
| Model numbers | 71324038, 71324039, 71324040, 71324041, 71324042, 71324043, 71324044, 71324045, 71324046, 71324047, 71324048, 71324049, 71324050, 71324051, 71324052, 71324053, 71324054, 71324055, 71324057, 71324059, 71325039, 71325040, 71325041, 71325042, 71325043 and 14 more |
Product
TANDEM (TM) INTL COCR SHELL UHMWPE LINER BIPOLAR, REF NUMBERS: 71324038, 71324039, 71324040, 71324041, 71324042, 71324043, 71324044, 71324045, 71324046, 71324047, 71324048, 71324049, 71324050, 71324051, 71324052, 71324053, 71324054, 71324055, 71324057, 71324059, 71325039, 71325040, 71325041,71325042, 71325043, 71325044, 71325045, 71325046, 71325047, 71325048, 71325049, 71325050, 71325051, 71325052, 71325053, 71325054, 71325055, 71325057, 71372047
Reason for recall
Some Bipolar shells were manufactured with an out of specification retainer groove.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0351-2017. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.