Device recall
Z-1238-2024: RAPIDSORB IPS Battery Pack, Sterile-Intended for use in non-load bearing…
FDA device recall · Class II · Synthes (USA) Products LLC
Key facts
| Recall number (Z-number) | Z-1238-2024 |
|---|---|
| Recall event | 93924 |
| Product | 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 |
| Product code | HBW |
| Recalling firm | Synthes (USA) Products LLC |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K141385 |
| FEI number | 3008812560 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 1–9 Recalled products with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recalls (products)
Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database