Potential sterility breach in sealing area of sterile pouch. If used, issue may result in moderate localized infection. If discovered prior to use, may result in clinically insignificant extension of surgery to find another readily available device.
Device user interface (screen) may freeze or become unresponsive to touch when operating in certain non-English language settings. Issue may cause delay or extension while alternate device is located.
Feb. 21, 20243:1 Dermacarrier…Class IIDue 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 tissue damage…
Oct. 11, 2023Zimmer Dermatome Blades- 10-pack boxes of blades…Class IISkin 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 for…
Aug. 8, 2018Zimmer Dermatone AN…Class IIDevices may have a loose control bar, which could compromise the ability to control the thickness of the graft. Devices could also have a loose width…
Feb. 21, 2018A.T.S… and 1 more productClass IIUpdated 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…
Nov. 16, 2016Zimmer¿ Air Dermatome II Handpiece Loaner…Class IIZimmer Biomet Surgical has received product complaints reporting that the surface coating applied to the device is blistering, peeling and…
May 20, 2015Zimmer 100 mL Hemovac Device Hemovac Mini Evacuator…Class IIIDevices were placed in a shipper carton without the appropriate number of the Instructions for Use (IFU). Packaging specifications require that each…
June 12, 2013The Zimmer Air Dermatome… and 2 more productsClass IIThis removal is in response to complaints alleging that the Zimmer Air Dermatomes and Zimmer Air Dermatome II products would either not operate or…
No recalls match.
How we match: a recall is listed here when the agency names Zimmer Surgical as the company that filed it. Sources: FDA enforcement reports and FDA-posted company announcements, CPSC recall notices and NHTSA recall campaigns.
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