CLASS II ONGOING Device recall · Reported 13 Mar 2024 · FDA Enforcement Report
Drill Bit/QC/ Sterile-surgical, orthopedic recalled
Synthes (USA) Products is recalling Drill Bit/QC/ Sterile-surgical, orthopedic, pneumatic powered & accessory/attachment, 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-1235-2024
- 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
- Hip & Knee Implants
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
1.5MM Drill Bit/QC/85MM Sterile-surgical, orthopedic, pneumatic powered & accessory/attachment Part Number: 310.15S
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: 10886982186034 Lot Number: 19P4364
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 | Rapidsorb IPS Battery Pack, Sterile-Intended for use recalled | 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 | 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 Hip & Knee Implants recalls
All 3,097| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Medline convenience kits labeled as: Femoral Pack, Medline Kit recalled | Medline Industries | Other | Nationwide |
| Device | CLASS II | Arvis Surgical Navigation System Gen recalled by Kico Knee Innovation | Kico Knee Innovation | Device Malfunction | 19 states |
| Device | CLASS II | Veritas Standard Reverse Total Shoulder Veritas Standard recalled | restor3d | Device Malfunction | Nationwide |
| Device | CLASS II | Endo-Model, Replacement Set, Tibial Plateau, right/left, L, Uhmwpe recalled | Waldemar Link GmbH & Co. KG (Mfg Site) | Other | IN |
| Device | CLASS II | U2 Total Knee System Femoral offset bushing recalled | United Orthopedic | Device Malfunction | Nationwide |