ZIMMER SURGICAL, INC. — FDA Facility Profile
ZIMMER SURGICAL, INC. is an FDA-registered facility (FEI 1526350) located in Dover, OH, US. RegDataLab tracks 3 FDA inspections at this facility.
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What FDA found at this site
- Latest inspection
- May 23, 2016: Voluntary Action Indicated (VAI)
- Inspections on record
- 3 (1 VAI, 2 NAI)
- Last OAI inspection
- None on record
- Warning letters
- None matched to this FEI. Many letters do not state an FEI: search warning letters by company name
- Recalls as the recalling firm
- 15, latest Jun 9, 2026
- Import refusals
- 1
Inspections and what FDA cited
| Date | Result | What FDA cited |
|---|---|---|
| May 23, 2016 | Voluntary Action Indicated (VAI) | Lack of or inadequate complaint procedures (21 CFR 820.198(a)) Nonconforming product, Lack of or inadequate procedures (21 CFR 820.90(a)) Records of complaint investigation (21 CFR 820.198(e)) Documentation (21 CFR 820.100(b)) |
| May 21, 2013 | No Action Indicated (NAI) | No citations listed |
| Oct 21, 2011 | No Action Indicated (NAI) | No citations listed |
Recalls
| Date | Class | Recall | Product and reason |
|---|---|---|---|
| Jun 9, 2026 | Class II | Z-2673-2026 | Brand Name: Sterile Tourniquet Hoses
Product Name: A.T.S¿ 4000 TS Tourniquet Systems Dual… and 1 more product Potential sterility breach in sealing area of sterile pouch. If used, issue may result in moderate localized infection. If discovered prior… |
| Dec 24, 2025 | Class II | Z-1201-2026 | Brand Name: Zimmer Tourniquet Systems
Product Name: A.T.S.¿ 5000TS Tourniquet… and 1 more product Device user interface (screen) may freeze or become unresponsive to touch when operating in certain non-English language settings. Issue may… |
| Nov 24, 2025 | Class II | Z-0924-2026 | Zimmer Air Dermatome, Model/Catalog Number: 00880100100 and 1 more product The devices may have a misaligned thickness control bar. |
| Jan 2, 2024 | Class II | Z-1078-2024 | 3:1 Dermacarrier, Model Number 00219501300, skin graft carrier 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 lead to minor… |
| Sep 5, 2023 | Class II | Z-0069-2024 | Zimmer Dermatome Blades- 10-pack boxes of blades. Intended for use with the dermatome… Skin grafts thin and non-uniform when using the affected blades. The issue would be identified at the time of use and may result in the need… |
| Jan 3, 2020 | Class II | Z-1356-2020 | Zimmer Sterile Disposable
Tourniquet Cuff with Protective
Sleeve and PLC, Dual Port… When inflating/deflating a single bladder, both bladders could potentially inflate/deflate due to a leak between the bladders. |
| Apr 16, 2019 | Class II | Z-1494-2019 | Zimmer Biomet Alvarado Knee Holder Base Plate Assembly and Foot Piece, & Alvarado II Base… Foreign Material in the Alvarado Knee Holder Base Plate Assembly and Foot Piece and Alvarado II Base Plate and Foot Piece due to potentially… |
| Jun 8, 2018 | Class II | Z-2602-2018 | Zimmer Dermatone AN, Model No. 88710100 Devices may have a loose control bar, which could compromise the ability to control the thickness of the graft. Devices could also have a… |
| Jul 27, 2017 | Class II | Z-0612-2018 | A.T.S. 4000TS Tourniquet Systems, Personalized Pressure.
Intended to be used by… and 1 more product 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… |
| Jul 4, 2016 | Class II | Z-0368-2017 | Zimmer¿ Air Dermatome II Handpiece Loaner, item number 01-8851-001-00. Device is packaged… Zimmer Biomet Surgical has received product complaints reporting that the surface coating applied to the device is blistering, peeling and… |
Facility details
- Company
- Zimmer Surgical Inc
- Location
- Dover, OH (US)
- Source
- device