A — Class II medical device recall Z-0612-2018
Terminated recall by Zimmer Surgical Inc, reported 2018-02-21, distributed nationwide. Updated on-device label and 3 pages of an updated Operator/Service Manual. Also, decrease from 3.8 meters (m)
| Recall number | Z-0612-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Zimmer Surgical Inc, Dover, OH, United States |
| Recall initiated | 2017-07-27 |
| Classified | 2018-02-14 |
| Reported by FDA | 2018-02-21 |
| Terminated | 2019-08-01 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, BR, CA, CL, CN, DK, FI, FR, GB, HK, IN, IT, JP, MX, MY, NL, PA, SE, SG, SV, TH, TW |
| Quantity | 8,231 devices |
| Reason classes | labeling |
| UPC / GTIN / UDI-DI | 00401411110003, 00401411110010, 00401411110027, 00401411110034, 00401411140017, 00401411140024, 00401411180006, 00401411180013, 00401411180020, 00401411200001, 00401411200018, 00401411250006, 00401411250013, 00401411250020, 00401412020004, 00401412020011, 00401412040002, 00401412050001, 00401412090007, 00401412090014, 00401412110002, 00401412120001, 00401412120018, 00401412120025, 00401412170006 and 475 more |
| Lot numbers | 62510549, 62510845, 62510927, 62510928, 62525817, 62525841, 62616141, 62616142, 62616143, 62616145, 62635795, 62635796, 62635797, 62635798, 62642282, 62673235, 62675189, 62676173, 62676174, 62683264, 62686165, 62686166, 62686167, 62688979, 62689574, 62689575, 62689602, 62689611, 62689620, 62689623, 62723751, 62723752, 62723753, 62723754, 62726132, 62726133, 62727350, 62728452, 62732712, 62732713 and 350 more |
| Serial numbers | 0020, 220011, 4010HAAU, 4013JAAA, 4013JAAB, 4013JAAC, 4013JAAD, 4013JAAE, 4013JAAF, 4013JAAG, 4013JAAH, 4013JAAJ, 4013JAAK, 4013JAAL, 4013JAAM, 4013JAAN, 4013JAAP, 4013JAAQ, 4013JAAR, 4013JAAS, 4013JAAT, 4013JAAU, 4013JAAW, 4013JABA, 4013JABB and 475 more |
| Model numbers | 60400040400 |
Product
A.T.S. 4000TS Tourniquet Systems, Personalized Pressure. Intended to be used by qualified professionals to temporarily occlude blood flow in a patient's extremities during surgical procedures on those extremities. .
Reason for recall
Updated on-device label and 3 pages of an updated Operator/Service Manual. Also, decrease from 3.8 meters (m) to 1.0 separation distance between the device and RF communication equipment.
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-0612-2018. 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.