Think Surgical Cutter Recall Due to Potential Head Detachment
Think Surgical is recalling 951 flat cutters used in total knee arthroplasty because the cutter head may detach from the shaft.
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: The recall involves a medical device with a risk of component failure during a surgical procedure, which fits the rubric criterion for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Think Surgical, Inc. is recalling 951 units of the Think Surgical Cutter, Flat, 6.2mm x 144mm (Part Number 106428). These devices are used to prepare bone for Total Knee Arthroplasty (TKA) and are intended for use only with the TCAT Computer-Assisted Tool.
The recall is being conducted because there is a potential for the cutter head to detach from the cutter shaft. The affected devices were distributed to New Jersey, New York, Ohio, and Texas, as well as to Korea. The recall covers specific lot numbers including 9158, 9519, 9209, 9230, 9269, 9288, 9834, 9869, 10201, 100496, 1626303, 9287, 9563, 9642, 9855, 9890, and 10313.
Healthcare providers and facilities should stop using these devices immediately and contact Think Surgical, Inc. for instructions on how to return or dispose of the affected units.
The recalled product
- Product
- Think Surgical Cutter, Flat, ¿6.2mm x 144mm. For use only with the TCAT Computer-Assisted Tool. Part Number 106428 The cutter is used to prepare the bone for the (TKA) Total Knee Arthroplasty.
- Manufacturer
- Think Surgical, Inc.
- Hazard
- Affected units
- 951
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 (17)
- Lot Numbers 9158
- 9519
- 9209
- 9230
- 9269
- 9288
- 9834
- 9869
- 10201
- 100496
- 1626303
- 9287
- 9563
- 9642
- 9855
- 9890
- 10313
Distribution
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