VOLT locking screw taps swapped between lots carry incorrect thread
The 2.4 VOLT Tap Locking Screw Tap is being recalled after a full lot swap with the Cortical Screw Tap left the bone taps with an incorrect thread.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Rubric level 3 covers risk-of-harm products where injury has not yet been reported: a bone tap cutting the wrong thread would not match the screw intended for it, and no injuries are stated in the source.
Plain-English summary
The 2.4 VOLT Tap Locking Screw Tap to 90 mm, part number 03.424.124-US, is being recalled. About 77 units were distributed across 21 US states. The FDA has classified this recall as Class II.
A full lot swap occurred between VOLT Locking Screw Tap 03.424.124 lot 68900P9 and Cortical Screw Tap 03.424.126 lot 68982P8, resulting in the bone taps having an incorrect thread.
Affected product is part number 03.424.124-US.
Facilities can identify affected taps by the part and lot numbers above, and may contact the recalling firm for further information.
The recalled product
- Product
- 2.4 VOLT TAP LOCKING SCREW TAP TO 90MM. Part Number: 03.424.124-US.
- Manufacturer
- Synthes (USA) Products LLC
- Affected units
- 77
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Part Number: 03.424.124-US. GTIN: 10886982335944. Lot Number: 68900P9.
Distribution
Part of a larger recall action
This product is one of 2 recalled by Synthes (USA) Products LLC under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 2 products in this recall →Related recalls
Same manufacturer · Synthes (USA) Products LLC
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