Z-0559-2015 Class II Terminated
FDA device recall Z-0559-2015 was initiated by Instrumed International, Inc. on September 8, 2014 and is designated Class II. Reason for recall: The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did not market these devices prior to September 26, 1976, and therefore, does not meet all FDA requirements … The recall status is terminated (terminated November 29, 2017). Affected quantity: 3 Schoitz weights.
Recall Details
- Product Type
- Devices
- Report Date
- December 17, 2014
- Initiation Date
- September 8, 2014
- Termination Date
- November 29, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 3 Schoitz weights
Product Description
Schoitz weights are manual devices used with Schoitz tonometers and are intended to measure intraocular pressure by applying a known force on the globe of the eye and measuring the amount of indentation produced (Schiotz type) or to measure intraocular tension by applanation (applying a small flat disk to the cornea) and are sold under the Ambler Surgical brand name.
Reason for Recall
The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did not market these devices prior to September 26, 1976, and therefore, does not meet all FDA requirements to market the devices as "Pre-Amendment" devices.
Distribution Pattern
Nationwide Distribution including AZ, CA, FL, IL, KS, MI, NC, OH, PA, TN, TX, and VA.
Code Information
1) Instrumed Product Name: Schoitz Weights 7.5 grams; Instrumed Product Number: 720-55812; Trade Name: Ambler Surgical; Ambler Surgical Product Name: Schoitz Weights 7.5 grams; Ambler Surgical Item Number: 5754B; Lot Number: 050411. 2) Instrumed Product Name: Schoitz Weights 15.0 grams; Instrumed Product Number: 720-55822; Trade Name: Ambler Surgical; Ambler Surgical Product Name: Schoitz Weights 15.0 grams; Ambler Surgical Item Number: 5754F; Lot Number: 050411.