Z-1693-2018Class II
Straumann Emdogain 0.15 ml 5-Pack. Enamel Matrix Derivative. Article Number 075.098W
Straumann USA, LLC / initiated 2018-03-23 / Terminated
Straumann Manufacturing, Inc. began a recall of Straumann Emdogain 0.15 ml 5-Pack. Enamel Matrix Derivative. Article Number 075.098W on . FDA classified it as Class II and gives the reason as "A change regarding the shelf life of a raw material was implemented without an appropriate submission of data demonstrating the continued efficacy of the product". As of , the recall status on record is Terminated.
Recall record
- Recall number
- Z-1693-2018
- Classification
- Class II
- Status
- Terminated
- Initiated
- Posted
- Terminated
- Recalling firm
- Straumann USA, LLC
- Product
- Straumann Emdogain 0.15 ml 5-Pack. Enamel Matrix Derivative. Article Number 075.098W
- Product code
- NQA Biologic Material, Dental
- Reason for recall
- A change regarding the shelf life of a raw material was implemented without an appropriate submission of data demonstrating the continued efficacy of the product.
- FDA root cause
- Component change control
- Action
- Customer notification letters were distributed 3/23/18. Action to be taken: 1. Check your inventory for the above listed article and lot numbers and return all unused/unpackaged Emdogain using the enclosed prepaid UPS label as indicated on the Customer Confirmation Form. Your account will be credited upon receipt. 2. If you have already unpacked the Emdogain from the outer box, the lot number on the blister package will be different. Please check your Emdogain for the syringe blister lot numbers listed above and return them for credit using the enclosed prepaid UPS label as indicated on the Customer Confirmation Form. 3. If you have already used the Emdogain with the above listed article and lot numbers, please document receipt of this Field Safety Notice in the applicable patient files. Complete and return the enclosed Customer Confirmation Form via fax to the number listed on the form. Please also report the outcome of the surgical treatment with this product on the enclosed Customer Treatment Outcome Form and fax the form to the number listed on the form. 4. For all cases complete and return the enclosed Customer Confirmation Form and return to Straumann using the enclosed UPS label (if returning product) or via fax (if notifying us the product has already been used). This notice needs to be passed on to all those who need to be aware within your organization or to any organization where the affected devices have been transferred. Updated Notification letters including an additional lot number were distributed beginning 4/18/18.
- Quantity in commerce
- 2381
- Distribution
- Distributed US Nationwide and Puerto Rico.
- Product codes and lots
- Lot NP737, Syringe Blister Lot NA438A, Exp 3/31/2019; Lot PG628, Syringe Blister Lot NF819A, Exp 3/31/2019; Lot PY816, Syringe Blister Lot PT888C, Exp 1/31/2020; Lot NY939, Syringe Blister Lot, NA438A, Exp 3/31/2019
Enforcement reports
One row per recalled product line| Recall number | Class | Status | Voluntary or mandated | Report date | Classified |
|---|---|---|---|---|---|
| Z-1693-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1694-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1695-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1696-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1697-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1698-2018 | Class II | Terminated | Voluntary: Firm initiated |
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