Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in United StatesLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field., part of Zimmer BiometLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 2 spellings of its name, each linked to the record.
As of Nov 15, 2026, FDA's public records list Zimmer Surgical with 28 device recalls and 1 510(k) clearance. The most recent is a device recall dated Jun 9, 2026: Brand Name: Sterile Tourniquet Hoses Product Name: A.T.S¿ 4000 TS Tourniquet Systems Si….
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date
A hatched bar is a year that is not over, so its count covers only part of the year.
| Jun 9, 2026 | Brand Name: Sterile Tourniquet Hoses Product Name: A.T.S¿ 4000 TS Tourniquet Systems Single Hose with CPC Connectors Model/Catalog Number:Class II · Potential sterility breach in sealing area of sterile pouch. If used, issue may result in moderate localized infection. | Device recalls |
| Jun 9, 2026 | Brand Name: Sterile Tourniquet Hoses Product Name: A.T.S¿ 4000 TS Tourniquet Systems Dual Hose with CPC Connectors Model/Catalog Number: 6Class II · Potential sterility breach in sealing area of sterile pouch. If used, issue may result in moderate localized infection. | Device recalls |
| Dec 24, 2025 | Brand Name: Zimmer Tourniquet Systems Product Name: A.T.S.¿ 3200TS Tourniquet Systems Model/Catalog Number: 60320010100 Software Version:Class II · Device user interface (screen) may freeze or become unresponsive to touch when operating in certain non-English language | Device recalls |
| Dec 24, 2025 | Brand Name: Zimmer Tourniquet Systems Product Name: A.T.S.¿ 5000TS Tourniquet Systems Model/Catalog Number: 60500010100 Software Version:Class II · Device user interface (screen) may freeze or become unresponsive to touch when operating in certain non-English language | Device recalls |
| Nov 24, 2025 | Zimmer Air Dermatome, Model/Catalog Number: 00880100100Class II · The devices may have a misaligned thickness control bar. | Device recalls |
| Nov 24, 2025 | Zimmer Dermatome AN, Model/Catalog Number: 88710100Class II · The devices may have a misaligned thickness control bar. | Device recalls |
| Jan 2, 2024 | 3:1 Dermacarrier, Model Number 00219501300, skin graft carrierClass II · Due to manufacturing issue, the product is labeled as 3:1 ratio, but the ridge pattern is a 1.5:1 ratio. The problem may | Device recalls |
| Sep 5, 2023 | Zimmer Dermatome Blades- 10-pack boxes of blades. Intended for use with the dermatome handpiece which is a skin grafting instrument that is Class II · Skin grafts thin and non-uniform when using the affected blades. The issue would be identified at the time of use and ma | Device recalls |
| Oct 15, 2019 | TotalShield II Surgical Helmet SystemK192194 · FYA | 510(k) clearances |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
