Recall Z-2971-2018 ยท HBL Holder, Head, Neurosurgical (Skull Clamp)
Pro-Med Instruments Gmbh
DORO LUCENT Locking Transitional Member, REF 1101.031 Component of headrest system used in open and percutaneous craniotomies and spinal surgeries
| Date | Sep 17, 2018 (initiated Jul 5, 2018) |
| Status | Terminated |
| Reason | The combination of two different design revisions of DORO LUCENT Base Unit, Locking Transitional Member, and Transitional Member within one set up might lead to a malfunction and failure of the headrest system. |
| Root cause | Component change control |
| Action | The firm initiated the recall by email on 07/05/2018. This stage is only relevant for hospitals / users who are in possession with concerned products of two different revisions (mix-up): a) Discontinue the use of the combination and quarantine the concerned products b) Contact pro med instruments for further instructions relating to temporary replacement possibilities |
| Quantity | 31 units |
| Distribution | Worldwide distribution to US states of CA, TX, TN, MS, GA, WV, and OH, Qatar, India, UK, Singapore, Australia, Germany, South Africa, Italy, and Japan |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K032331 | DORO RADIOLUCENT HEADREST SYSTEM AND HORSESHOE HEADRESTS,AND NON-RADIOLUCENT J-ARM RETRACTOR SYSTEM (ALUMINUM ALLOY) Pro-Med Instruments GmbH, Nov 20, 2003 |