Urgent Field Safety Notice For Tiloop Pro Plus P / Tiloop Pro Plus A / Tiloop Total 6 Plus / Tiloop Total 4 Plus By Pfm Medical Titanium Gmbh
Recall Summary TiLOOP PRO PLUS P, TiLOOP PRO PLUS A, TiLOOP Total 6 PLUS, and TiLOOP Total 4 PLUS surgical mesh devices made by pfm medical titanium gmbh are being recalled due to a safety concern identified during risk assessment. These devices were distributed in Germany and the EU. This is classified as a Class I recall, indicating a serious safety issue.
- Recalling firm
- Urgent Field Safety Notice for TiLOOP PRO PLUS P / TiLOOP PRO PLUS A / TiLOOP Total 6 PLUS / TiLOOP Total 4 PLUS by pfm
- Product
- s Tasks of the BfArM Risk assessment Field corrective actions Urgent Field Safety Notice for TiLOOP PRO PLUS P / TiLOOP PRO PLUS A / TiLOOP Total 6 PLUS / TiLOOP Total 4 PLUS by pfm medical titanium gmbh 2026
- Reason
- assessment Field corrective actions Urgent Field Safety Notice for TiLOOP PRO PLUS P / TiLOOP PRO PLUS A / TiLOOP Total 6 PLUS / TiLOOP Total 4 PLUS by pfm medical titanium gmbh 2026
- Classification
- Class I
- Category
- medical device recall
- Country
- Germany
- Agency
- BFARM
- Recall date
- 2026-06-15
- Status
- Ongoing
- Distribution
- Germany / EU
Official recall notice from BFARM
Recall details on Nibble Recalls: https://trynibble.app/recalls/059ee84d-7957-4fff-9c98-bedacd4c668e