Universal Chuck Surgical Instrument Handle May Detach and Release Ball Bearings
The Universal Chuck instrument handle may loosen and release ball bearings onto the surgical field. If not recovered, these bearings could delay surgery and potentially cause infection or tissue damage.
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: This is a Class II FDA recall involving a risk-of-harm scenario where internal components may fall into the surgical field potentially causing tissue damage, infection, or surgical delay. No illnesses, injuries, or hospitalizations have been reported. Per the severity rubric, risk-of-harm products where injury has not yet been reported receive a High classification.
Plain-English summary
Synthes (USA) Products LLC is recalling the Universal Chuck, an instrument handle used in orthopedic surgical nailing systems including the TN-ADVANCED, TFN-ADVANCED, RFN-ADVANCED, and FRN-ADVANCED systems, as well as Flexible Monobloc Reamers. Approximately 600 units have been distributed nationwide.
The Universal Chuck may loosen and detach when the instrument becomes jammed and the user attempts to manually free it. Internal ball bearings may then fall out onto the surgical field. If the bearings are not recovered during the procedure, they could remain in the patient's tissue, potentially causing surgical delays, adverse tissue reactions, and infection.
Affected products can be identified by the specific lot/serial numbers: 20013101, 20052701, 20228901, 20229301, 20253901, 20558602, 20698102, 20777201, 21869701, 21983904, and 21995301. Healthcare providers and surgical teams should contact Synthes (USA) Products LLC for information on remedial measures or replacement of affected instrument handles.
The recalled product
- Product
- Universal Chuck-The Universal Chuck is an Instrument Handle provided as an alternative instrument available for use in the TN-ADVANCED" Tibial Nailing System (TNA), TFN-ADVANCED" Proximal Femoral Nailing System (TFNA), RFN-ADVANCED" Retrograde Femoral Nailing System (RFNA)…
- Manufacturer
- Synthes (USA) Products LLC
- Affected units
- 600
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 (10)
- Lot/Serial No.: 20013101
- 20052701
- 20228901
- 20229301
- 20253901
- 20558602
- 20698102
- 20777201 21869701
- 21983904
- 21995301 GTIN: 10886982297372
Distribution
Distributed nationwide across the United States.
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