AAP Implantate Soft Tissue Retractor Recalled for Manufacturing Defect
AAP Implantate AG is recalling 7 units of soft tissue retractors because they may not be fully removed during manufacturing, potentially leaving debris in patients.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a risk-of-harm product where injury has not yet been reported, fitting the criteria for a High severity score.
Plain-English summary
AAP Implantate AG is recalling 7 units of the Soft tissue retractor, radiolucent, REF IU 7971-00. The affected units are identified by lot numbers I012, I025, and I028. The product was distributed worldwide.
The recall was initiated because the company determined that the soft tissue retractor is not always removed during the sawing process. This manufacturing issue can result in damage to the retractor, causing abrasion debris to develop and remain in the body (in vivo).
Healthcare providers and patients who have used these specific devices should contact AAP Implantate AG for further instructions regarding the recall and potential removal of the device.
The recalled product
- Product
- aap Implantate AG, Soft tissue retractor, radiolucent, REF IU 7971-00
- Manufacturer
- AAP Implantate Ag
- Affected units
- 7
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- Lot Numbers: I012
- I025
- I028
Distribution
Distribution scope not specified by the agency.
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