CLASS II Device recall · Reported 21 Aug 2013 · FDA Enforcement Report
Drill Bit. This is a component within the PediLoc Locking recalled
OrthoPediatrics is recalling Drill Bit. This is a component within the PediLoc Locking Plate System utilized to, distributed nationwide in the US. The recall was initiated on 24 Jul 2013 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-1941-2013
- FDA event ID
- 65828
- Recalling firm
- OrthoPediatrics, Warsaw, IN
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 24 Jul 2013
- FDA classified
- 9 Aug 2013
- Reported
- 21 Aug 2013
- Type
- Voluntary: Firm initiated
- Customers notified by
- Telephone
- Reason category
- Labeling Errors
- Device type
- Other Medical Devices
Timeline
| 24 Jul 2013 | Recall initiated by company | |
| 9 Aug 2013 | Classified by FDA | +16 days |
| 21 Aug 2013 | 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
OrthoPediatrics has initiated a voluntary recall of Part # 01-1050-002, 2.5mm Drill Bit, Lot #91300335. Only drill bits that are in their original packaging are being recalled. The description on the package of this drill bit has a wrong size in the description (3.2mm). The recall affects only packaged devices still in original packaging due to misbranding of the product. The drill bit itself has
Product as listed by the FDA
3.2mm Drill Bit. This is a component within the PediLoc Locking Plate System utilized to pre-drill a hole in bone prior to placement of a bone screw.
Where it was distributed
Nationwide distribution, including the states of MO, MI, WA, FL, NY, TN, CO, AZ, VA, TX, CA, MN, LA, NC, and UT.
Nationwide ArizonaCaliforniaColoradoFloridaLouisianaMichiganMinnesotaMissouriNorth CarolinaNew YorkTennesseeTexasUtahVirginiaWashington
Questions about this recall
Is Drill Bit. This is a component within the PediLoc Locking Plate System utilized to recalled?
Yes. OrthoPediatrics recalled Drill Bit. This is a component within the PediLoc Locking Plate System utilized to on 24 Jul 2013. The recall is Class II and its status is Terminated. Recall number Z-1941-2013.
Why was it recalled?
OrthoPediatrics has initiated a voluntary recall of Part # 01-1050-002, 2.5mm Drill Bit, Lot #91300335. Only drill bits that are in their original packaging are being recalled. The description on the package of this drill bit has a wrong size in the description (3.2mm). The recall affects only packaged devices still in original packaging due to misbranding of the product. The drill bit itself has
Which lots are affected?
LOT 91300335 - Catalogue Number 01-1050-0002
Where was it sold?
Nationwide distribution, including the states of MO, MI, WA, FL, NY, TN, CO, AZ, VA, TX, CA, MN, LA, NC, and UT.
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 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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