Recall Z-0559-2015
Instrumed International, Inc. · initiated September 8, 2014
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
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.
Codes / lots: 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.
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The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did not market these devices prior to September 26, 1976, and therefore, does not meet all FDA requirements to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.
FDA-determined cause: No Marketing Application
Action taken
Instrumed sent an URGENT: MEDICAL DEVICE MARKET WITHDRAWAL letters dated October 9, 2014 to all affected customers. The letter included instructions for customers to: 1) examine their inventory to determine if there are any recalled devices; 2) complete and return the enclosed Confirmation Request Form; 3) return the recalled devices; and 4) share the recall information with facility staff. Customers with questions were instructed to contact Instrumed by telephone at 847-908-6119.
Details
- Recall number
- Z-0559-2015
- Initiated
- September 8, 2014
- Posted by FDA
- December 16, 2014
- Terminated
- November 29, 2017
- Product code
- HKY – Tonometer, Manual
- Quantity
- 3 Schoitz weights
- Distribution
- Nationwide Distribution including AZ, CA, FL, IL, KS, MI, NC, OH, PA, TN, TX, and VA.
- Recalling firm
- Instrumed International, Inc., Schaumburg, IL
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| Z-0545-2015 Class II | McKenzie Perforator Drills are bone cutting and drilling instruments that are used…The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did not market… | 09/08/2014Terminated |
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| Z-0548-2015 Class II | Hudson cranial drill sets (w/ brace and 5 attachments) are bone cutting and drilling…The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did not market… | 09/08/2014Terminated |
| Z-0549-2015 Class II | Galt trephines are bone cutting and drilling instruments that are used without a power…The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did not market… | 09/08/2014Terminated |
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