Pega Medical Recalls SLIM Handle Components Due to Jamming Risk
Pega Medical Inc. is recalling 19 SLIM Handle components because an internal ring may detach, causing the handle to jam with the driver.
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 is classified as FDA Class II, and the source describes a mechanical defect (jamming) that poses a risk of harm during use, but no injuries or illnesses are reported in the text.
Plain-English summary
Pega Medical Inc. is recalling 19 units of the SLIM Handle (catalogue #: SLM-HND100), a component of the Simple Locking Intramedullary (SLIM) System. The recall is due to a defect where an internal Connector Ring may detach, which could cause the handle to jam with the Driver.
The affected units are identified by Lot # 150115-09, 160427-01, and A162-02. These products were distributed in California, Delaware, Florida, Illinois, North Carolina, Nebraska, New York, and Tennessee.
Healthcare providers and facilities should stop using the affected SLIM Handles and contact Pega Medical Inc. for instructions on returning the devices.
The recalled product
- Product
- SLIM Handle - catalogue #: SLM-HND100 a component of Simple Locking Intramedullary (SLIM) System
- Manufacturer
- Pega Medical Inc.
- Affected units
- 19
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 (2)
- Lot # 150115-09
- 160427-01 and A162-02
Distribution
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