Reported Apr 15, 2020 · Terminated
aap Implantate AG, Soft tissue retractor, radiolucent, REF IU 7971-00
AAP Implantate Ag
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: AAP Implantate Ag · Lorenzweg 5 · Berlin, N/A · N/A
Is this the product you have?
- aap Implantate AG, Soft tissue retractor, radiolucent, REF IU 7971-00
- Lot codes and dates
- Lot Numbers
I012I025I028
- Lot Numbers
- Amount recalled
- 7 units
Why it was recalled
The company has become aware that the soft tissue retractor is not always removed during the sawing process. This can result in damage to the soft tissue retractor in which abrasion debris can develop and remain in vivo.
This product could cause temporary or reversible health problems — stop using it.
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