Medtronic Poly Component Trial Knee Implants Recalled for Cracked Dovetails
Medtronic is recalling 72 Poly Component Trial knee implants because their dovetails were observed as cracked or broken.
What this means for you
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 is classified as FDA Class II, and the hazard involves a structural defect (cracked or broken dovetails) in a medical device where injury has not yet been reported, fitting the 'High' severity criteria for risk-of-harm products.
Plain-English summary
Medtronic Sofamor Danek USA Inc is recalling 72 units of the Poly Component Trial, UCCS, which is part of the Responsive Orthopedics (RO) Total Knee Arthroplasty (TKA) System. The recall covers various sizes and configurations, including REF 90-SRK-170310 through 90-SRK-170614, with specific lot numbers ranging from TU53733-01 to TU53737-04.
The recall was initiated because the dovetails of the poly trials, Beta 2.0, were observed as either cracked or broken. The RO Total Knee Arthroplasty System is intended to restore alignment, stability, range of motion, and alleviate pain by replacing the articulating surfaces of the knee joint.
The affected units were distributed in the United States to Arkansas and Massachusetts. Consumers and healthcare providers should stop using the affected devices and contact Medtronic Sofamor Danek USA Inc for further instructions.
The recalled product
- Product
- Poly Component Trial, UCCS, packaged in the following sizes and configurations: a) Poly Comp Trial - UCCS 3x10, REF 90-SRK-170310 b) Poly Comp Trial - UCCS 3x12, REF 90-SRK-170312 c) Poly Comp Trial - UCCS 3x14, REF 90-SRK-170314 d) Poly Comp Trial - UCCS 4x10, REF 90-SRK-1
- Manufacturer
- Medtronic Sofamor Danek USA Inc
- Affected units
- 72
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 (13)
- Lot Numbers: a) REF 90-SRK-170310
- TU53733-01 b) REF 90-SRK-170312
- TU53736-01 c) REF 90-SRK-170314
- TU53737-01 d) REF 90-SRK-170410
- TU53733-02 e) REF 90-SRK-170412
- TU53736-02 f) REF 90-SRK-170414
- TU53737-02 g) REF 90-SRK-170510
- TU53733-03 h) REF 90-SRK-170512
- TU53736-03 i) REF 90-SRK-170514
- TU53737-03 j) REF 90-SRK-170610
- TU53733-04 k) REF 90-SRK-170612
- TU53736-04 l) REF 90-SRK-170614
- TU53737-04
Distribution
Part of a larger recall action
This product is one of 4 recalled by Medtronic Sofamor Danek USA Inc 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.
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