Recall Z-0727-2023 ยท LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
Corin Ltd
Corin BIOLOX DELTA MOD HEAD, 036mm EX LONG +8mm, REF 104.3615
| Date | Dec 19, 2022 (initiated Nov 8, 2022) |
| Status | Open, Classified |
| Reason | The BIOLOX Delta Ceramic Head size 36XL is labelled as the size 32XL and vice-versa. |
| Root cause | Under Investigation by firm |
| Action | The firm issued a FIELD SAFETY NOTICE/RECALL LETTER on 11/08/2022 by email. The notice explained the issue, potential risk to health, and post implantation recommendations. The following actions were requested: - Return the device from the filed to Coring USA Limited, Paramount Drive, Raynham, MA 02767, USA - Complete the acknowledgment of receipt and forward to vigilance@coringroup.com to confirm receipt of the Field Safety Notice/Recall Letter. For further information concerning this event, contact: vigilance@coringroup.com |
| Quantity | 12 units |
| Distribution | US Nationwide distribution in the states of FL, GA, MA, MI, Ok, PA, TX. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.