Recall Z-1238-2024 ยท HBW Fastener, Plate, Cranioplasty
Synthes (USA) Products LLC
RAPIDSORB IPS Battery Pack, Sterile-Intended for use in non-load bearing fracture repair and reconstructive procedures of the craniofacial skeleton (excluding the upper and lower jaw) in pediatric and adult populations. Part Number: 530.553.01S
| Date | Mar 1, 2024 (initiated Jan 24, 2024) |
| Status | Open, Classified |
| Reason | Products not sterilized, sterility cannot be confirmed |
| Root cause | Process control |
| Action | DePuy Synthesis issued Urgent Medical Device Recall (Removal Letter ) via email on 1/24/24. In the US, impacted consignees will be notified via mail, sales consultants and email. OUS Affiliates will be notified via email and will inform their impacted customers per their country regulations and procedures. Letter states reason for recall, health risk and action to take: Steps: 1. Examine your inventory immediately to determine if you have the subject products and quarantine them immediately. DO NOT USE THE SUBJECT PRODUCTS. Ref: 2348044 Page 2 of 3 2. Contact your DePuy Synthes Sales Consultan |
| Quantity | 10 units |
| Distribution | Worldwide distribution - US Nationwide and the countries of Argentina, Austria, Australia, Belgium, Canada, Czech Republic, Germany, Spain, Finland, France, United Kingdom, Ireland, South Korea, Kuwait, Mexico, Netherlands, Slovakia, Taiwan, South Africa. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K141385 | DEPUY SYNTHES INJECTABLE POLYMER SYSTEM (IPS) Depuy Synthes Companies of Johnson & Johnson, Mar 27, 2015 |