CLASS II ONGOING Device recall · Reported 13 Mar 2024 · FDA Enforcement Report
Rapidsorb IPS Battery Pack, Sterile-Intended for use recalled
Synthes (USA) Products is recalling Rapidsorb IPS Battery Pack, Sterile-Intended for use in non-load bearing fracture repair, distributed nationwide in the US. The recall was initiated on 24 Jan 2024 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1238-2024
- FDA event ID
- 93924
- Recalling firm
- Synthes (USA) Products, West Chester, PA
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 24 Jan 2024
- FDA classified
- 1 Mar 2024
- Reported
- 13 Mar 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Sterility
- Device type
- Masks, Gloves & PPE
Timeline
| 24 Jan 2024 | Recall initiated by company | |
| 1 Mar 2024 | Classified by FDA | +37 days |
| 13 Mar 2024 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Products not sterilized, sterility cannot be confirmed
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
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
Where it was distributed
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.
Questions about this recall
Why was it recalled?
Products not sterilized, sterility cannot be confirmed
Which lots are affected?
UDI: 10887587057262 Lot Number: 499P371
Where was it sold?
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.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
8 other products · FDA event 93924This product is part of a recall event; the main page for the event is Opal, Intervertebral Cage, 10x32mm, h recalled by Synthes (USA) Products.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Opal, Intervertebral Cage, 10x32mm, h recalled by Synthes (USA) Products | Synthes (USA) Products | Sterility | Nationwide | |
| CLASS II | Titanium Hindfoot Arthrodesis Cannulated Nails EX recalled | Synthes (USA) Products | Sterility | Nationwide | |
| CLASS II | TFNA Femoral Nail, right, 130¿, L-Intended recalled | Synthes (USA) Products | Sterility | Nationwide | |
| CLASS II | Drill Bit/QC/ Sterile-surgical, orthopedic recalled | Synthes (USA) Products | Sterility | Nationwide | |
| CLASS II | Va-lcp Clavicle Plate 2.7, shaft, CS1, right-Intended recalled | Synthes (USA) Products | Sterility | Nationwide | |
| CLASS II | Drill Bit/QC/Gold/ Sterile-surgical, orthopedic recalled | Synthes (USA) Products | Sterility | Nationwide | |
| CLASS II | RIA Tube Assembly, minimum length, sterile- intended recalled | Synthes (USA) Products | Sterility | Nationwide | |
| CLASS II | TFNA Femoral Nail, right, 130¿, L-Intended recalled | Synthes (USA) Products | Sterility | Nationwide |
More recalls from Synthes (USA) Products
All 164| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | 2.4 Volt(tm) Tap Cortex Screw recalled by Synthes (USA) Products | Synthes (USA) Products | Other | Nationwide |
| Device | CLASS II | 2.4 Volt Tap Locking Screw Tap recalled by Synthes (USA) Products | Synthes (USA) Products | Other | Nationwide |
| Device | CLASS II | Low Prof Lckng Screw, F/im Nail / L / Xl25/ Ster recalled | Synthes (USA) Products | Packaging Defects | Nationwide |
| Device | CLASS II | Low Prof Lckng Screw, F/im Nail / L / Xl25/ Ster recalled | Synthes (USA) Products | Packaging Defects | Nationwide |
| Device | CLASS II | Stardrive Scrwdrvr Shft/T4/Self-retaining/Hxc-Intended recalled | Synthes (USA) Products | Other | Nationwide |
Other Masks, Gloves & PPE recalls
All 450| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Opportunity Pro recalled by American Nitrile Operations | American Nitrile Operations | Device Malfunction | Nationwide |
| Device | CLASS II | Opportunity Flex recalled by American Nitrile Operations | American Nitrile Operations | Device Malfunction | Nationwide |
| Device | CLASS II | Performance Pro recalled by American Nitrile Operations | American Nitrile Operations | Device Malfunction | Nationwide |
| Device | CLASS II | P28 Phanton Intramedullary Nail System recalled by Paragon 28 | Paragon 28 | Sterility | Nationwide |
| Device | CLASS II | Cyberknife Treatment Deliver System equipped recalled | Accuray | Device Malfunction | Nationwide |